Tarceva and Capecitabine for Pancreatic Cancer

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Genentech, Inc.; Massachusetts General Hospital; Roche Global Development
• Treatments: Capecitabine; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors)

• Only patients with measurable disease

• ECOG performance status < or equal to 1

• Life expectancy >12 weeks

• Signed informed consent

• Failed or intolerance to first-line therapy for metastatic disease with a gemcitabine-containing regimen. Patients may have received adjuvant therapy in addition to one prior regimen for metastatic disease.

• >4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities

• >4 weeks must have elapsed from the participation in any investigational drug study

• Laboratory values:

• ANC > 1500/mm3;

• Hemoglobin > 9.0 gm/dl;

• Platelets > 100,000/mm3;

• SGOT <2.5 X upper limit of normal; or <5 X upper limit of normal if evidence of liver metastases; Alkaline phosphatase < 2.5 X upper limit of normal; or < 5 X upper limit of normal if evidence of liver metastases; Total bilirubin < 1.5 X upper limit of normal; Creatinine clearance > 50 cc/min (by Cockroft - Gault or as determined from a 24-hour urine collection).

Exclusion Criteria:

• Prior therapy with capecitabine or epidermal growth factor receptor (EGFR) inhibitors

• More than one prior chemotherapy treatment regimen for metastatic disease

• Clinically apparent central nervous system (CNS) metastases or carcinomatous meningitis

• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or heart attack within the last 12 months).

• Major surgery within 4 weeks of the start of study treatment, without complete recovery.

• Evidence of CNS metastases (unless CNS metastases have been stable for > 3 months) or history of uncontrolled seizures, central nervous system disorders

• Uncontrolled serious medical or psychiatric illness

• Women must not be pregnant or lactating

• Concurrent radiation therapy

• Other active malignancy

• Inability to swallow tablets

• Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome

• Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil