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Annals of Oncology 13:1490-1496, 2002
© 2002 European Society for Medical Oncology

Original Paper

Phase I study of weekly oxaliplatin plus irinotecan in previously treated patients with metastatic colorectal cancer

N. Kemeny+, W. Tong, M. Gonen, J. Stockman, C. Di Lauro, J. Teitcher, P. White, C. Price, L. Saltz, S. Sharma and M. A. Graham

Memorial Sloan-Kettering Cancer Center, New York, NY, USA

Received 7 March 2002; accepted 21 March 2002

Background:

In vitro synergy between Oxal (oxaliplatin) and CPT-11 (irinotecan) has been reported. Oxaliplatin exerts its antineoplastic activity through the formation of platinum–DNA adducts. Resistance to oxaliplatin is through repair of these adducts, which is inhibited by irinotecan.

Patients and methods:

Oxaliplatin and irinotecan were administered weekly for 4 weeks followed by a 2-week rest period. The dose of oxaliplatin was escalated first, starting at 30 mg/m2. Once a dose of 60 mg/m2 was attained, the weekly dose of irinotecan was escalated, from 40 mg/m2 to 85 mg/m2. A total of 49 previously treated patients with metastatic colorectal cancer were entered in order to establish the maximum tolerated dose. Pharmacokinetics of oxaliplatin and irinotecan were analyzed.

Results:

Forty-nine patients were evaluable for toxicity. The recommended phase II doses for this combination are oxaliplatin 60 mg/m2 and irinotecan 50 mg/m2, weekly x 4 q 6 weeks. Diarrhea was the most common dose-limiting toxicity. No pharmacological interactions were noted between oxaliplatin and irinotecan. Twelve of the 47 evaluable patients (26%) achieved a partial response.

Conclusion:

Weekly combination of oxaliplatin and irinotecan appears to be a well tolerated and active regimen in patients previously treated for metastatic colorectal cancer. Further investigations of this regimen are warranted.

Key words: colorectal cancer, irinotecan, oxaliplatin


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