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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Antoine Lacassagne
• Treatments: Capecitabine; Erlotinib Hydrochloride; Gemcitabine

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