A phase I/II study of capecitabine given on a week on/week off schedule combined with bevacizumab and oxaliplatin for patients with untreated advanced colorectal cancer

Rajesh Sehgal, Barry C. Lembersky, Kiran K. Rajasenan, Theodore L. Crandall, Edward Balaban, Richard A. Pinkerton, Patrick Kane, Amy Schmotzer, Herbert Zeh, Douglas M. Potter, Ramesh K. Ramanathan

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Abstract

Background: A week on/week off capecitabine schedule with oxaliplatin/bevacizumab was evaluated in patients with metastatic colorectal cancer (mCRC). Patients and Methods: Forty patients were required. The projected median progression-free survival (PFS) was 12 months (81% power, 1-sided level 0.1 log-rank test). Capecitabine dose was 2500 mg/m2/day on days 1-7 (n = 11) and was increased to 3000 mg/m 2 /day (n = 29) in combination with oxaliplatin (85 mg/m 2 ) and bevacizumab (5 mg/kg). Cycles were repeated every 2 weeks. Results: Patient characteristics included Eastern Cooperative Oncology Group (ECOG) performance status 0 (n = 24) or 1 (n = 15); median age of 62 years (range, 38-81 years). Median cycles administered were 7 (range, 1-25), corresponding to 3.5 months' treatment duration. Pertinent grade 3/4 toxicities seen were diarrhea (18%), hand-foot syndrome (10%), and peripheral neuropathy (10%). Bowel perforation in 1 patient (3%) and 1 death due to a cerebral hemorrhage (3%) were noted. Response rate (RR) was 38% (1 complete and 14 partial responses). Median PFS was 8.6 months (95% confidence interval [CI], 4.7-10.2 months). Median overall survival was 17.2 months (95% CI, 10.4-24.2 months). Conclusion: The first US experience of capecitabine to our knowledge (3000 mg/m2 on days 1-7) in combination with oxaliplatin/ bevacizumab in mCRC does not appear to have advantages compared with current standard first-line mCRC treatment regimens.

Original languageEnglish (US)
Pages (from-to)117-120
Number of pages4
JournalClinical Colorectal Cancer
Volume10
Issue number2
DOIs
StatePublished - Jan 1 2011

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oxaliplatin
Colorectal Neoplasms
Appointments and Schedules
Disease-Free Survival
Hand-Foot Syndrome
Confidence Intervals
Cerebral Hemorrhage
Peripheral Nervous System Diseases
Diarrhea
Bevacizumab
Capecitabine

All Science Journal Classification (ASJC) codes

  • Oncology
  • Gastroenterology

Cite this

Sehgal, Rajesh ; Lembersky, Barry C. ; Rajasenan, Kiran K. ; Crandall, Theodore L. ; Balaban, Edward ; Pinkerton, Richard A. ; Kane, Patrick ; Schmotzer, Amy ; Zeh, Herbert ; Potter, Douglas M. ; Ramanathan, Ramesh K. / A phase I/II study of capecitabine given on a week on/week off schedule combined with bevacizumab and oxaliplatin for patients with untreated advanced colorectal cancer. In: Clinical Colorectal Cancer. 2011 ; Vol. 10, No. 2. pp. 117-120.
@article{f0a5687a9ba343e1a5b300931e236e6f,
title = "A phase I/II study of capecitabine given on a week on/week off schedule combined with bevacizumab and oxaliplatin for patients with untreated advanced colorectal cancer",
abstract = "Background: A week on/week off capecitabine schedule with oxaliplatin/bevacizumab was evaluated in patients with metastatic colorectal cancer (mCRC). Patients and Methods: Forty patients were required. The projected median progression-free survival (PFS) was 12 months (81{\%} power, 1-sided level 0.1 log-rank test). Capecitabine dose was 2500 mg/m2/day on days 1-7 (n = 11) and was increased to 3000 mg/m 2 /day (n = 29) in combination with oxaliplatin (85 mg/m 2 ) and bevacizumab (5 mg/kg). Cycles were repeated every 2 weeks. Results: Patient characteristics included Eastern Cooperative Oncology Group (ECOG) performance status 0 (n = 24) or 1 (n = 15); median age of 62 years (range, 38-81 years). Median cycles administered were 7 (range, 1-25), corresponding to 3.5 months' treatment duration. Pertinent grade 3/4 toxicities seen were diarrhea (18{\%}), hand-foot syndrome (10{\%}), and peripheral neuropathy (10{\%}). Bowel perforation in 1 patient (3{\%}) and 1 death due to a cerebral hemorrhage (3{\%}) were noted. Response rate (RR) was 38{\%} (1 complete and 14 partial responses). Median PFS was 8.6 months (95{\%} confidence interval [CI], 4.7-10.2 months). Median overall survival was 17.2 months (95{\%} CI, 10.4-24.2 months). Conclusion: The first US experience of capecitabine to our knowledge (3000 mg/m2 on days 1-7) in combination with oxaliplatin/ bevacizumab in mCRC does not appear to have advantages compared with current standard first-line mCRC treatment regimens.",
author = "Rajesh Sehgal and Lembersky, {Barry C.} and Rajasenan, {Kiran K.} and Crandall, {Theodore L.} and Edward Balaban and Pinkerton, {Richard A.} and Patrick Kane and Amy Schmotzer and Herbert Zeh and Potter, {Douglas M.} and Ramanathan, {Ramesh K.}",
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Sehgal, R, Lembersky, BC, Rajasenan, KK, Crandall, TL, Balaban, E, Pinkerton, RA, Kane, P, Schmotzer, A, Zeh, H, Potter, DM & Ramanathan, RK 2011, 'A phase I/II study of capecitabine given on a week on/week off schedule combined with bevacizumab and oxaliplatin for patients with untreated advanced colorectal cancer', Clinical Colorectal Cancer, vol. 10, no. 2, pp. 117-120. https://doi.org/10.1016/j.clcc.2011.03.008

A phase I/II study of capecitabine given on a week on/week off schedule combined with bevacizumab and oxaliplatin for patients with untreated advanced colorectal cancer. / Sehgal, Rajesh; Lembersky, Barry C.; Rajasenan, Kiran K.; Crandall, Theodore L.; Balaban, Edward; Pinkerton, Richard A.; Kane, Patrick; Schmotzer, Amy; Zeh, Herbert; Potter, Douglas M.; Ramanathan, Ramesh K.

In: Clinical Colorectal Cancer, Vol. 10, No. 2, 01.01.2011, p. 117-120.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A phase I/II study of capecitabine given on a week on/week off schedule combined with bevacizumab and oxaliplatin for patients with untreated advanced colorectal cancer

AU - Sehgal, Rajesh

AU - Lembersky, Barry C.

AU - Rajasenan, Kiran K.

AU - Crandall, Theodore L.

AU - Balaban, Edward

AU - Pinkerton, Richard A.

AU - Kane, Patrick

AU - Schmotzer, Amy

AU - Zeh, Herbert

AU - Potter, Douglas M.

AU - Ramanathan, Ramesh K.

PY - 2011/1/1

Y1 - 2011/1/1

N2 - Background: A week on/week off capecitabine schedule with oxaliplatin/bevacizumab was evaluated in patients with metastatic colorectal cancer (mCRC). Patients and Methods: Forty patients were required. The projected median progression-free survival (PFS) was 12 months (81% power, 1-sided level 0.1 log-rank test). Capecitabine dose was 2500 mg/m2/day on days 1-7 (n = 11) and was increased to 3000 mg/m 2 /day (n = 29) in combination with oxaliplatin (85 mg/m 2 ) and bevacizumab (5 mg/kg). Cycles were repeated every 2 weeks. Results: Patient characteristics included Eastern Cooperative Oncology Group (ECOG) performance status 0 (n = 24) or 1 (n = 15); median age of 62 years (range, 38-81 years). Median cycles administered were 7 (range, 1-25), corresponding to 3.5 months' treatment duration. Pertinent grade 3/4 toxicities seen were diarrhea (18%), hand-foot syndrome (10%), and peripheral neuropathy (10%). Bowel perforation in 1 patient (3%) and 1 death due to a cerebral hemorrhage (3%) were noted. Response rate (RR) was 38% (1 complete and 14 partial responses). Median PFS was 8.6 months (95% confidence interval [CI], 4.7-10.2 months). Median overall survival was 17.2 months (95% CI, 10.4-24.2 months). Conclusion: The first US experience of capecitabine to our knowledge (3000 mg/m2 on days 1-7) in combination with oxaliplatin/ bevacizumab in mCRC does not appear to have advantages compared with current standard first-line mCRC treatment regimens.

AB - Background: A week on/week off capecitabine schedule with oxaliplatin/bevacizumab was evaluated in patients with metastatic colorectal cancer (mCRC). Patients and Methods: Forty patients were required. The projected median progression-free survival (PFS) was 12 months (81% power, 1-sided level 0.1 log-rank test). Capecitabine dose was 2500 mg/m2/day on days 1-7 (n = 11) and was increased to 3000 mg/m 2 /day (n = 29) in combination with oxaliplatin (85 mg/m 2 ) and bevacizumab (5 mg/kg). Cycles were repeated every 2 weeks. Results: Patient characteristics included Eastern Cooperative Oncology Group (ECOG) performance status 0 (n = 24) or 1 (n = 15); median age of 62 years (range, 38-81 years). Median cycles administered were 7 (range, 1-25), corresponding to 3.5 months' treatment duration. Pertinent grade 3/4 toxicities seen were diarrhea (18%), hand-foot syndrome (10%), and peripheral neuropathy (10%). Bowel perforation in 1 patient (3%) and 1 death due to a cerebral hemorrhage (3%) were noted. Response rate (RR) was 38% (1 complete and 14 partial responses). Median PFS was 8.6 months (95% confidence interval [CI], 4.7-10.2 months). Median overall survival was 17.2 months (95% CI, 10.4-24.2 months). Conclusion: The first US experience of capecitabine to our knowledge (3000 mg/m2 on days 1-7) in combination with oxaliplatin/ bevacizumab in mCRC does not appear to have advantages compared with current standard first-line mCRC treatment regimens.

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