Pancreatic Cancer Clinical Trial
Official title:
Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given
together with capecitabine and erlotinib in treating patients with advanced pancreatic
cancer.
OBJECTIVES:
Primary
- Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride,
capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.
Secondary
- 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, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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