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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: erlotinib hydrochloride
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gemcitabine, capecitabine, erlotinib<br> | Drug: capecitabine<br> <br> Drug: erlotinib hydrochloride<br> <br> Drug: gemcitabine hydrochloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical or laboratory toxicities as assessed by CTC |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer