Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
- Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride,
capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.
- Analyze the limiting toxicities according to CTC.
- Analyze the toxicity according to CTC.
- Determine the recommended dose.
- Determine the pharmacokinetic dosages of the three drugs.
- Analyze interactions between the drugs.
OUTLINE: This is a multicenter study.
Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30
minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib
hydrochloride once daily on days 1-28.
Allocation: Non-Randomized, Primary Purpose: Treatment
Clinical or laboratory toxicities as assessed by CTC
Centre Antoine Lacassagne