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

Centre Antoine Lacassagne

Status and phase: Completed; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: capecitabine; Drug: gemcitabine hydrochloride; Drug: erlotinib hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00885066

2007-005072-14 (EudraCT Number)

CALACASS-CAPERGEM

INCA-RECF0622

2007/36

ROCHE-CALACASS-CAPERGEM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

gemcitabine, capecitabine, erlotinib

Experimental group

Treatment:

Drug: erlotinib hydrochloride

Drug: gemcitabine hydrochloride

Drug: capecitabine