Pancreatic Cancer Research

Clinical trialPhase 1Completed

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

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

NCT00885066↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Finished, no results posted
Phase
Phase 1
Status
Completed
Study type
Interventional
Start
May 2008
Expected end
October 2009
Enrollment
30 participants
Sites
1
Primary outcomes
Clinical or laboratory toxicities as assessed by CTC
Sponsor
Other
Results posted
No
Last update
23 April 2026

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Papers 1

The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.