Conditions: Pancreatic Cancer
Keywords: Pancreas Cancer Pancreatic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

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.

Arms:
arm 1: Erlotinib (oral) 150 mg/day x 12 months Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months

Interventions: intervention 1: Gemcitabine intervention 2: Erlotinib
Intervention descriptions: intervention 1: 1500mg/m2 IV over 150 min IV q 2 weeks 4 months intervention 2: 150 mg/d Daily, oral 12 months

Protocol document: