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Jeffrey L. Berenberg - One of the best experts on this subject based on the ideXlab platform.
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placebo controlled trial to determine the effectiveness of a urea lactic acid based topical Keratolytic Agent for prevention of capecitabine induced hand foot syndrome north central cancer treatment group study n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Rui Qin, Jeffrey L. BerenbergAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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placebo controlled trial to determine the effectiveness of a urea lactic acid based topical Keratolytic Agent for prevention of capecitabine induced hand foot syndrome north central cancer treatment group study n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Jeffrey L. Berenberg, Charles L LoprinziAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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Placebo-Controlled Trial to Determine the Effectiveness of a Urea/Lactic Acid–Based Topical Keratolytic Agent for Prevention of Capecitabine-Induced Hand-Foot Syndrome: North Central Cancer Treatment Group Study N05C5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Jeffrey L. BerenbergAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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Evaluation of a urea/lactic acid-based topical Keratolytic Agent (ULABTKA) for prevention of capecitabine-induced hand and foot syndrome (HFS): NCCTG trial N05C5.
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Diana Christian, Daniel Satele, Jeffrey L. Berenberg, John W. Kugler, Patrick J. Flynn, Charles L LoprinziAbstract:9017 Background: HFS is a dose-limiting toxicity of capecitabine, occurring in 43-71% of patients. No effective preventative treatment has been definitively demonstrated. Urea/lactic acid have hydrating and Keratolytic properties. Pilot data suggest that they may prevent HFS. The purpose of this trial was to evaluate the prophylactic use of a ULABTKA for capecitabine-induced HFS. Methods: A randomized double-blind phase III trial evaluated 137 patients (pts) receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Pts were randomized to a ULABTKA vs. a placebo cream, which was applied to the hands and feet BID for 21 days after the start of capecitabine. Pts completed a HFS Diary (HFSD) daily while applying the cream. HFS toxicity grade (CTCAE v 3.0) was also collected at baseline and at the end of each cycle. The primary endpoint was assessed by comparing the percentage of pts in each group who self-reported moderate severity (or worse) HFS during cyc...
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evaluation of a urea lactic acid based topical Keratolytic Agent ulabtka for prevention of capecitabine induced hand and foot syndrome hfs ncctg trial n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Diana Christian, Daniel Satele, Jeffrey L. Berenberg, John W. Kugler, Patrick J. Flynn, Charles L LoprinziAbstract:9017 Background: HFS is a dose-limiting toxicity of capecitabine, occurring in 43-71% of patients. No effective preventative treatment has been definitively demonstrated. Urea/lactic acid have hydrating and Keratolytic properties. Pilot data suggest that they may prevent HFS. The purpose of this trial was to evaluate the prophylactic use of a ULABTKA for capecitabine-induced HFS. Methods: A randomized double-blind phase III trial evaluated 137 patients (pts) receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Pts were randomized to a ULABTKA vs. a placebo cream, which was applied to the hands and feet BID for 21 days after the start of capecitabine. Pts completed a HFS Diary (HFSD) daily while applying the cream. HFS toxicity grade (CTCAE v 3.0) was also collected at baseline and at the end of each cycle. The primary endpoint was assessed by comparing the percentage of pts in each group who self-reported moderate severity (or worse) HFS during cyc...
Sherry L. Wolf - One of the best experts on this subject based on the ideXlab platform.
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placebo controlled trial to determine the effectiveness of a urea lactic acid based topical Keratolytic Agent for prevention of capecitabine induced hand foot syndrome north central cancer treatment group study n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Rui Qin, Jeffrey L. BerenbergAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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placebo controlled trial to determine the effectiveness of a urea lactic acid based topical Keratolytic Agent for prevention of capecitabine induced hand foot syndrome north central cancer treatment group study n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Jeffrey L. Berenberg, Charles L LoprinziAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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Placebo-Controlled Trial to Determine the Effectiveness of a Urea/Lactic Acid–Based Topical Keratolytic Agent for Prevention of Capecitabine-Induced Hand-Foot Syndrome: North Central Cancer Treatment Group Study N05C5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Jeffrey L. BerenbergAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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Evaluation of a urea/lactic acid-based topical Keratolytic Agent (ULABTKA) for prevention of capecitabine-induced hand and foot syndrome (HFS): NCCTG trial N05C5.
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Diana Christian, Daniel Satele, Jeffrey L. Berenberg, John W. Kugler, Patrick J. Flynn, Charles L LoprinziAbstract:9017 Background: HFS is a dose-limiting toxicity of capecitabine, occurring in 43-71% of patients. No effective preventative treatment has been definitively demonstrated. Urea/lactic acid have hydrating and Keratolytic properties. Pilot data suggest that they may prevent HFS. The purpose of this trial was to evaluate the prophylactic use of a ULABTKA for capecitabine-induced HFS. Methods: A randomized double-blind phase III trial evaluated 137 patients (pts) receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Pts were randomized to a ULABTKA vs. a placebo cream, which was applied to the hands and feet BID for 21 days after the start of capecitabine. Pts completed a HFS Diary (HFSD) daily while applying the cream. HFS toxicity grade (CTCAE v 3.0) was also collected at baseline and at the end of each cycle. The primary endpoint was assessed by comparing the percentage of pts in each group who self-reported moderate severity (or worse) HFS during cyc...
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evaluation of a urea lactic acid based topical Keratolytic Agent ulabtka for prevention of capecitabine induced hand and foot syndrome hfs ncctg trial n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Diana Christian, Daniel Satele, Jeffrey L. Berenberg, John W. Kugler, Patrick J. Flynn, Charles L LoprinziAbstract:9017 Background: HFS is a dose-limiting toxicity of capecitabine, occurring in 43-71% of patients. No effective preventative treatment has been definitively demonstrated. Urea/lactic acid have hydrating and Keratolytic properties. Pilot data suggest that they may prevent HFS. The purpose of this trial was to evaluate the prophylactic use of a ULABTKA for capecitabine-induced HFS. Methods: A randomized double-blind phase III trial evaluated 137 patients (pts) receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Pts were randomized to a ULABTKA vs. a placebo cream, which was applied to the hands and feet BID for 21 days after the start of capecitabine. Pts completed a HFS Diary (HFSD) daily while applying the cream. HFS toxicity grade (CTCAE v 3.0) was also collected at baseline and at the end of each cycle. The primary endpoint was assessed by comparing the percentage of pts in each group who self-reported moderate severity (or worse) HFS during cyc...
Charles L Loprinzi - One of the best experts on this subject based on the ideXlab platform.
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placebo controlled trial to determine the effectiveness of a urea lactic acid based topical Keratolytic Agent for prevention of capecitabine induced hand foot syndrome north central cancer treatment group study n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Jeffrey L. Berenberg, Charles L LoprinziAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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Evaluation of a urea/lactic acid-based topical Keratolytic Agent (ULABTKA) for prevention of capecitabine-induced hand and foot syndrome (HFS): NCCTG trial N05C5.
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Diana Christian, Daniel Satele, Jeffrey L. Berenberg, John W. Kugler, Patrick J. Flynn, Charles L LoprinziAbstract:9017 Background: HFS is a dose-limiting toxicity of capecitabine, occurring in 43-71% of patients. No effective preventative treatment has been definitively demonstrated. Urea/lactic acid have hydrating and Keratolytic properties. Pilot data suggest that they may prevent HFS. The purpose of this trial was to evaluate the prophylactic use of a ULABTKA for capecitabine-induced HFS. Methods: A randomized double-blind phase III trial evaluated 137 patients (pts) receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Pts were randomized to a ULABTKA vs. a placebo cream, which was applied to the hands and feet BID for 21 days after the start of capecitabine. Pts completed a HFS Diary (HFSD) daily while applying the cream. HFS toxicity grade (CTCAE v 3.0) was also collected at baseline and at the end of each cycle. The primary endpoint was assessed by comparing the percentage of pts in each group who self-reported moderate severity (or worse) HFS during cyc...
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evaluation of a urea lactic acid based topical Keratolytic Agent ulabtka for prevention of capecitabine induced hand and foot syndrome hfs ncctg trial n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Diana Christian, Daniel Satele, Jeffrey L. Berenberg, John W. Kugler, Patrick J. Flynn, Charles L LoprinziAbstract:9017 Background: HFS is a dose-limiting toxicity of capecitabine, occurring in 43-71% of patients. No effective preventative treatment has been definitively demonstrated. Urea/lactic acid have hydrating and Keratolytic properties. Pilot data suggest that they may prevent HFS. The purpose of this trial was to evaluate the prophylactic use of a ULABTKA for capecitabine-induced HFS. Methods: A randomized double-blind phase III trial evaluated 137 patients (pts) receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Pts were randomized to a ULABTKA vs. a placebo cream, which was applied to the hands and feet BID for 21 days after the start of capecitabine. Pts completed a HFS Diary (HFSD) daily while applying the cream. HFS toxicity grade (CTCAE v 3.0) was also collected at baseline and at the end of each cycle. The primary endpoint was assessed by comparing the percentage of pts in each group who self-reported moderate severity (or worse) HFS during cyc...
Smitha Menon - One of the best experts on this subject based on the ideXlab platform.
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placebo controlled trial to determine the effectiveness of a urea lactic acid based topical Keratolytic Agent for prevention of capecitabine induced hand foot syndrome north central cancer treatment group study n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Rui Qin, Jeffrey L. BerenbergAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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placebo controlled trial to determine the effectiveness of a urea lactic acid based topical Keratolytic Agent for prevention of capecitabine induced hand foot syndrome north central cancer treatment group study n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Jeffrey L. Berenberg, Charles L LoprinziAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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Placebo-Controlled Trial to Determine the Effectiveness of a Urea/Lactic Acid–Based Topical Keratolytic Agent for Prevention of Capecitabine-Induced Hand-Foot Syndrome: North Central Cancer Treatment Group Study N05C5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Jeffrey L. BerenbergAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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Evaluation of a urea/lactic acid-based topical Keratolytic Agent (ULABTKA) for prevention of capecitabine-induced hand and foot syndrome (HFS): NCCTG trial N05C5.
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Diana Christian, Daniel Satele, Jeffrey L. Berenberg, John W. Kugler, Patrick J. Flynn, Charles L LoprinziAbstract:9017 Background: HFS is a dose-limiting toxicity of capecitabine, occurring in 43-71% of patients. No effective preventative treatment has been definitively demonstrated. Urea/lactic acid have hydrating and Keratolytic properties. Pilot data suggest that they may prevent HFS. The purpose of this trial was to evaluate the prophylactic use of a ULABTKA for capecitabine-induced HFS. Methods: A randomized double-blind phase III trial evaluated 137 patients (pts) receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Pts were randomized to a ULABTKA vs. a placebo cream, which was applied to the hands and feet BID for 21 days after the start of capecitabine. Pts completed a HFS Diary (HFSD) daily while applying the cream. HFS toxicity grade (CTCAE v 3.0) was also collected at baseline and at the end of each cycle. The primary endpoint was assessed by comparing the percentage of pts in each group who self-reported moderate severity (or worse) HFS during cyc...
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evaluation of a urea lactic acid based topical Keratolytic Agent ulabtka for prevention of capecitabine induced hand and foot syndrome hfs ncctg trial n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Diana Christian, Daniel Satele, Jeffrey L. Berenberg, John W. Kugler, Patrick J. Flynn, Charles L LoprinziAbstract:9017 Background: HFS is a dose-limiting toxicity of capecitabine, occurring in 43-71% of patients. No effective preventative treatment has been definitively demonstrated. Urea/lactic acid have hydrating and Keratolytic properties. Pilot data suggest that they may prevent HFS. The purpose of this trial was to evaluate the prophylactic use of a ULABTKA for capecitabine-induced HFS. Methods: A randomized double-blind phase III trial evaluated 137 patients (pts) receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Pts were randomized to a ULABTKA vs. a placebo cream, which was applied to the hands and feet BID for 21 days after the start of capecitabine. Pts completed a HFS Diary (HFSD) daily while applying the cream. HFS toxicity grade (CTCAE v 3.0) was also collected at baseline and at the end of each cycle. The primary endpoint was assessed by comparing the percentage of pts in each group who self-reported moderate severity (or worse) HFS during cyc...
Kendrith M. Rowland - One of the best experts on this subject based on the ideXlab platform.
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placebo controlled trial to determine the effectiveness of a urea lactic acid based topical Keratolytic Agent for prevention of capecitabine induced hand foot syndrome north central cancer treatment group study n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Rui Qin, Jeffrey L. BerenbergAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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placebo controlled trial to determine the effectiveness of a urea lactic acid based topical Keratolytic Agent for prevention of capecitabine induced hand foot syndrome north central cancer treatment group study n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Jeffrey L. Berenberg, Charles L LoprinziAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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Placebo-Controlled Trial to Determine the Effectiveness of a Urea/Lactic Acid–Based Topical Keratolytic Agent for Prevention of Capecitabine-Induced Hand-Foot Syndrome: North Central Cancer Treatment Group Study N05C5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Sachdev P. Thomas, Robert Delaune, Diana Christian, Eduardo R. Pajon, Daniel Satele, Jeffrey L. BerenbergAbstract:Purpose Hand-foot syndrome (HFS) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. This trial was conducted on the basis of preliminary data that a urea/lactic acid–based topical Keratolytic Agent (ULABTKA) may prevent HFS. Patients and Methods A randomized, double-blind phase III trial evaluated 137 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Patients were randomly assigned to a ULABTKA versus a placebo cream, which was applied to the hands and feet twice per day for 21 days after the start of capecitabine. Patients completed an HFS diary (HFSD) daily. HFS toxicity grade (Common Terminology Criteria for Adverse Events [CTCAE] v3.0) was also collected at baseline and at the end of each cycle. The primary end point was the incidence of moderate/severe HFS symptoms in the first treatment cycle, based on the patient-reported HFSD. Results The percentage of pa...
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Evaluation of a urea/lactic acid-based topical Keratolytic Agent (ULABTKA) for prevention of capecitabine-induced hand and foot syndrome (HFS): NCCTG trial N05C5.
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Diana Christian, Daniel Satele, Jeffrey L. Berenberg, John W. Kugler, Patrick J. Flynn, Charles L LoprinziAbstract:9017 Background: HFS is a dose-limiting toxicity of capecitabine, occurring in 43-71% of patients. No effective preventative treatment has been definitively demonstrated. Urea/lactic acid have hydrating and Keratolytic properties. Pilot data suggest that they may prevent HFS. The purpose of this trial was to evaluate the prophylactic use of a ULABTKA for capecitabine-induced HFS. Methods: A randomized double-blind phase III trial evaluated 137 patients (pts) receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Pts were randomized to a ULABTKA vs. a placebo cream, which was applied to the hands and feet BID for 21 days after the start of capecitabine. Pts completed a HFS Diary (HFSD) daily while applying the cream. HFS toxicity grade (CTCAE v 3.0) was also collected at baseline and at the end of each cycle. The primary endpoint was assessed by comparing the percentage of pts in each group who self-reported moderate severity (or worse) HFS during cyc...
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evaluation of a urea lactic acid based topical Keratolytic Agent ulabtka for prevention of capecitabine induced hand and foot syndrome hfs ncctg trial n05c5
Journal of Clinical Oncology, 2010Co-Authors: Sherry L. Wolf, Smitha Menon, Kendrith M. Rowland, Diana Christian, Daniel Satele, Jeffrey L. Berenberg, John W. Kugler, Patrick J. Flynn, Charles L LoprinziAbstract:9017 Background: HFS is a dose-limiting toxicity of capecitabine, occurring in 43-71% of patients. No effective preventative treatment has been definitively demonstrated. Urea/lactic acid have hydrating and Keratolytic properties. Pilot data suggest that they may prevent HFS. The purpose of this trial was to evaluate the prophylactic use of a ULABTKA for capecitabine-induced HFS. Methods: A randomized double-blind phase III trial evaluated 137 patients (pts) receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. Pts were randomized to a ULABTKA vs. a placebo cream, which was applied to the hands and feet BID for 21 days after the start of capecitabine. Pts completed a HFS Diary (HFSD) daily while applying the cream. HFS toxicity grade (CTCAE v 3.0) was also collected at baseline and at the end of each cycle. The primary endpoint was assessed by comparing the percentage of pts in each group who self-reported moderate severity (or worse) HFS during cyc...
