Pancreatic Cancer Clinical Trial
Official title:
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed by single agent erlotinib for a total of 12 months.
PATIENT POPULATION Resected pancreatic cancer patients (R0 resection) within 10 weeks of
surgery will be eligible, provided that they meet standard eligibility criteria.
STUDY DESIGN Phase II, open-label trial of erlotinib and gemcitabine. SAFETY PLAN Safety as
assessed by CTCAE 3.0 STUDY TREATMENT Erlotinib 150 mg/day x 12 months. (oral) Gemcitabine
1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months Patients will be monitored with serial
CT scans for the first 2 years after completion of therapy.
Clinical Practice: Therapy will be administered as an outpatient. Primary Evaluations: Time
to recurrence CONCOMITANT THERAPY AND CLINICAL PRACTICE No other anti-cancer therapy will be
allowed while on study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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