TY - JOUR
T1 - Phase II trial of oxaliplatin/irinotecan/5-fluorouracil/leucovorin for metastatic colorectal cancer
AU - McWilliams, Robert R.
AU - Goetz, Matthew P.
AU - Morlan, Bruce W.
AU - Salim, Muhammad
AU - Rowland, Kendrith M.
AU - Krook, James E.
AU - Ames, Matthew M.
AU - Erlichman, Charles
N1 - Funding Information:
This study was conducted as a trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service grants CA-25224, CA-37404, CA-35195, CA-35269, and CA35431 from the National Cancer Institute Department of Health and Human Services.
PY - 2007/5
Y1 - 2007/5
N2 - Background: Individually, oxaliplatin and irinotecan have substantial activity in metastatic colorectal cancer (CRC) in combination with 5-fluorouracil/leucovorin.A combination regimen using all 4 agents could potentially increase response rates in CRC. Patients and Methods: A multicenter phase II trial of oxaliplatin 85 mg/m2 on day I, irinotecan 175 mg/m2 on day 1,5-fluorouracil 240 mg/m2 by 90-minute infusion on days 2-5, and leucovorin 20 mg/m2 on days 2-5 of a 21-day cycle was undertaken in patients with CRC through the North Central Cancer Treatment Group. The primary endpoint was response rate, with secondary endpoints of toxicity and quality of life. Results: Of 14 patients enrolled (13 evaluable), 3 partial responses were seen (23%; 95% confidence interval, 5%-54%), and 9 patients had stable disease (69%). Toxicity was significant, with 1 (8%) grade 5 event (diarrhea and dehydration) and 3 (23%) grade 4 events (leukopenia and diarrhea). The study was closed to further enrollment because of toxicity. Conclusion: The 4-drug regimen was extremely toxic. Future studies incorporating irinotecan- and oxaliplatin-based therapy should consider alternative schedules.
AB - Background: Individually, oxaliplatin and irinotecan have substantial activity in metastatic colorectal cancer (CRC) in combination with 5-fluorouracil/leucovorin.A combination regimen using all 4 agents could potentially increase response rates in CRC. Patients and Methods: A multicenter phase II trial of oxaliplatin 85 mg/m2 on day I, irinotecan 175 mg/m2 on day 1,5-fluorouracil 240 mg/m2 by 90-minute infusion on days 2-5, and leucovorin 20 mg/m2 on days 2-5 of a 21-day cycle was undertaken in patients with CRC through the North Central Cancer Treatment Group. The primary endpoint was response rate, with secondary endpoints of toxicity and quality of life. Results: Of 14 patients enrolled (13 evaluable), 3 partial responses were seen (23%; 95% confidence interval, 5%-54%), and 9 patients had stable disease (69%). Toxicity was significant, with 1 (8%) grade 5 event (diarrhea and dehydration) and 3 (23%) grade 4 events (leukopenia and diarrhea). The study was closed to further enrollment because of toxicity. Conclusion: The 4-drug regimen was extremely toxic. Future studies incorporating irinotecan- and oxaliplatin-based therapy should consider alternative schedules.
KW - Overall survival
KW - Quality of life
KW - Time to progression
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U2 - 10.3816/CCC.2007.n.017
DO - 10.3816/CCC.2007.n.017
M3 - Article
C2 - 17553200
AN - SCOPUS:34250668782
SN - 1533-0028
VL - 6
SP - 516
EP - 521
JO - Clinical colorectal cancer
JF - Clinical colorectal cancer
IS - 7
ER -