Phase II study of cisplatin combined with weekly gemcitabine in the treatment of patients with metastatic pancreatic carcinoma.

BACKGROUND/AIMS: Combination therapy of gemcitabine and cisplatin has been reported as an effective regimen for advanced pancreatic cancer. However, the toxicity and synergism are known to depend on the schedule of cisplatin. A phase II study was undertaken to determine the efficacy of a single dose of cisplatin in combination with weekly gemcitabine in patients with metastatic pancreatic carcinoma. METHODS: Patients with measurable, metastatic pancreatic carcinoma, not locally advanced diseases, were included. The patients were treated with a combination of gemcitabine 1,000 mg/m(2) i.v. over 30 min administered on days 1, 8, and 15 of each cycle and cisplatin 75 mg/m(2) i.v. administered 6 h after gemcitabine infusion on day 1 with adequate prehydration. Response and toxicity were assessed according to World Health Organization criteria. RESULTS: A total of 52 patients, 5 with recurrent disease after curative operation, were enrolled from January 2000 to March 2004. The objective response rate was 16 of 52 patients (1 complete response and 15 partial response). Disease stabilization was seen in 10 patients (20.8%). The median survival was 11.8 months (95% CI, 10.7-13.0 months), with 76.1% of patients alive at 6 months and 50% alive at 12 months. The median time to progression was 6.1 months (95% CI, 4.16-7.98 months). Major toxicity profiles were thrombocytopenia and neutropenia. CONCLUSIONS: The modified regimen of a single dose of cisplatin per cycle in combination with weekly gemcitabine appeared to have a more favorable therapeutic index and comparable toxicity profiles.