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

NCT ID: NCT00885066

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-10-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

gemcitabine, capecitabine, erlotinib

Group Type: EXPERIMENTAL

capecitabine

Intervention Type: DRUG

erlotinib hydrochloride

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

Interventions

capecitabine

Intervention Type: DRUG

erlotinib hydrochloride

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Advanced disease
• No standard curative therapy available
• Must have received prior first-line chemotherapy
• No brain metastasis

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• Life expectancy ≥ 8 weeks
• ANC ≥ 1.5 x 10^9/ L
• Platelet count ≥ 130 x 10^9/ L
• Hemoglobin ≥ 10 g/dL
• Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
• Bilirubin ≤ 1.5 times ULN
• Creatinine ≤ 130 mmol/L OR creatinine clearance > 30 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No intolerance or hypersensitivity to any of the drugs being tested
• No history of interstitial lung disease
• No history of severe cardiac disease
• No serious uncontrolled infection
• No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
• Must not be deprived of liberty or under guardianship
• Must not be on probation

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior erlotinib hydrochloride
• No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
• More than 14 days since participation in another clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Francois

Role: PRINCIPAL_INVESTIGATOR

Centre Antoine Lacassagne

Locations

Centre Antoine Lacassagne

Nice, , France

Countries

France

Other Identifiers

CALACASS-CAPERGEM

Identifier Type: -

Identifier Source: secondary_id

ROCHE-CALACASS-CAPERGEM

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0622

Identifier Type: -

Identifier Source: secondary_id

2007-005072-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2007/36

Identifier Type: -

Identifier Source: org_study_id