Tarceva and Capecitabine for Pancreatic Cancer

Completed · Phase 2

Conditions studied: Pancreatic Cancer, Neoplasm Metastasis

In brief

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

Key facts

Study ID

NCT00125021

Run by

Dana-Farber Cancer Institute

People needed

32

Starts

2003-10-01

Expected to finish

2008-09-01

Last updated by the study team

2009-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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