Spots Global Cancer Trial Database for A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer

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Trial Identification

Brief Title: A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer

Official Title: A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer

Study ID: NCT00336700

Conditions

Pancreatic Cancer

Interventions

Gemcitabine

Erlotinib

Study Description

Brief Summary: 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.

Detailed Description: 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.