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  • Volume 6
  •  Issue 9
  • Publication Date: September 2007


Phase II Trial of 5-Fluorouracil/Leucovorin/Gemcitabine/Cisplatin as Second-Line Treatment in Patients with Metastatic or Recurrent Colorectal Carcinoma: A Cancer Therapeutics Research Group Study


Alex Y. Chang, Gilberto Lopes, Koo Wen Hsin, Robert Lim, Foo Kian Fong, John Wong

Background: Second-line treatment of relapsed or metastatic colorectal cancer (CRC) after failure of treatment with a fluoropyrimidine is composed of oxaliplatin in combination with a fluoropyrimidine or an irinotecan-containing regimen. Cisplatin and gemcitabine are synergistic in preclinical studies, as is 5-fluorouracil (5-FU) combined with either agent. Fixed-rate infusional gemcitabine is more effective than bolus administration in animal models. Patients and Methods: A 2-stage phase II trial was conducted to assess the efficacy (the primary endpoint was response rate) and safety of a regimen consisting of 5-FU 400 mg/m2 as an intravenous bolus at the middle of a 60-minute infusion of leucovorin 100 mg/m2, followed by gemcitabine 800 mg/m2 over 80 minutes, and cisplatin 20 mg/m2 over 15 minutes. Treatment was repeated weekly for 3 weeks followed by a 1-week rest. Patients with advanced CRC were eligible if they had experienced treatment failure with fluoropyrimidine-based therapy. Results: Nineteen patients were enrolled.The median age was 60 years; 15 patients were men and 4 were women.Twelve patients had colon cancer and 7 had rectal cancer. Sites of metastasis were as follows: liver (n = 10), lung (n = 8), skin (n = 1), and non-regional lymph nodes (n = 1). All patients had an Eastern Cooperative Oncology Group performance status of 0/1. A total of 44 cycles of chemotherapy were delivered (median, 2 cycles; range, 1-5 cycles). One patient exhibited a partial response (5%), 8 had stable disease (42%), and 5 experienced disease progression (26%); another 5 patients were nonevaluable (26%).The median time to progression was 8 weeks and median survival was 36 weeks. Grade 3/4 toxicities were as follows: diarrhea (n = 1), dyspnea (n = 1), pneumonia (n = 1), neutropenia (n = 2), and thrombocytopenia (n = 1). Conclusion: Despite acceptable toxicity and a reasonable overall survival, the combination of 5-FU/leucovorin/gemcitabine/cisplatin does not seem to improve current standard therapy in the second-line treatment of patients with CRC in whom a first-line fluoropyrimidine-containing regimen has failed.

Key words: Chemotherapy, Fluoropyrimidines, Survival



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