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Annals of Oncology 13:116-120, 2002
© 2002 European Society for Medical Oncology

A phase II trial of weekly intravenous gemcitabine and cisplatin with continuous infusion fluorouracil in patients with metastatic renal cell carcinoma

C. M. George1,+, N. J. Vogelzang1,2,3, B. I. Rini1, F. J. Geoffroy4, P. Kollipara5 and W. M. Stadler1,2,3

1Section of Hematology/Oncology, Department of Medicine; 2Section of Urology, Department of Surgery; 3Cancer Research Center, University of Chicago; 4Methodist Medical Center, Peoria, IL; 5Fort Wayne Medical Oncology/Hematology Inc, Fort Wayne, IN, USA

Received 9 April 2001; revised 25 June 2001; accepted 17 August 2001.

Background

We reported previously that the combination of gemcitabine and continuous infusion fluorouracil (5-FU) has activity in renal cell carcinoma [1]. Based upon in vitro synergy of gemcitabine/cisplatin and 5-FU/cisplatin, we hypothesized that the addition of cisplatin could improve the objective response rate of gemcitabine and 5-FU with manageable toxicity.

Patients and methods

Twenty-one patients with metastatic renal cell carcinoma (RCC) and a Cancer and Leukemia Group B performance status of 0 to 2 were enrolled. Ten had received prior systemic therapy. Treatment consisted of gemcitabine 600 mg/m2 and cisplatin 20 mg/m2 on days 1, 8 and 15 of each 28-day cycle. Continuous infusion 5-FU was given from day 1 to day 21.

Results

No complete responses and one partial response were observed for an objective response rate of 5% (95% confidence interval 0% to 24%). Two minor responses (25% to 50% regression) were also observed. The median overall survival was 10 months with 35% of patients surviving at 1 year. Grade 3–4 myelosuppression (mostly thrombocytopenia) occurred in nine (43%) patients. Nausea/vomiting and neuropathy were dose-limiting in an additional five patients. Only 51% of treatment cycles were delivered on time and without dose reduction.

Conclusions

The addition of cisplatin to gemcitabine and 5-FU did not improve the objective response rate of gemcitabine and 5-FU alone and added to the toxicity. Due to the cumulative toxicity, further trials with this cisplatin-containing regimen in RCC are not indicated.

Key words: cisplatin, fluorouracil, gemcitabine, phase II, renal cell carcinoma


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