Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
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.
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers|
- Clinical or laboratory toxicities as assessed by CTC [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
|Experimental: gemcitabine, capecitabine, erlotinib||Drug: capecitabine Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885066
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Principal Investigator:||Eric Francois||Centre Antoine Lacassagne|