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

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: capecitabine; Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride

• Registration Number: NCT00885066
• Lead Sponsor: Centre Antoine Lacassagne

Brief 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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-04-18
• Study First Submitted QC: 2009-04-18
• Study First Posted: 2009-04-21
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-08
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gemcitabine, capecitabine, erlotinib	gemcitabine hydrochloride	-
gemcitabine, capecitabine, erlotinib	capecitabine	-
gemcitabine, capecitabine, erlotinib	erlotinib hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Clinical or laboratory toxicities as assessed by CTC	1 year

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France