NCT00885066

Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer

Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Centre Antoine Lacassagne · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	capecitabine
DRUG	erlotinib hydrochloride
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-09-01
• Completion: 2009-10-01
• First posted: 2009-04-21
• Last updated: 2025-09-30

Locations

1 site across 1 country: France