Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma
OBJECTIVES: I. Assess the efficacy of docetaxel and gemcitabine vs docetaxel and cisplatin
in patients with metastatic or locoregionally advanced pancreatic cancer. II. Assess the
toxicity, response rate, duration of response, time to progression, survival, performance
status, and weight associated with these treatment regimens in these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patents are randomized to one
of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and
8 and docetaxel IV over 1 hour on day 8. Arm II: Patients receive docetaxel IV over 1 hour
followed by cisplatin IV over 1 hour on day 1. Treatment is repeated every 21 days for 6
courses in the absence of disease progression or unacceptable toxicity. Patients are
followed every 6 weeks until disease progression, and then every 8 weeks until death.
PROJECTED ACCRUAL: Up to 82 patients (41 per arm) will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Manfred Lutz, MD
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
United States: Federal Government