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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer|
- Time to recurrence [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
- Level of expression and mutation of EGFR and its downstream markers on tumor tissue and correlate with patient outcome. [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]
- Serum levels of EGFR protein before and after administration of erlotinib and correlate with tumor recurrence and patient survival. [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Gemcitabine and Erlotinib
Erlotinib (oral) 150 mg/day x 12 months Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months
1500mg/m2 IV over 150 min IV q 2 weeks 4 months
Other Name: GemzarDrug: Erlotinib
150 mg/d Daily, oral 12 months
Other Name: Tarceva
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.
|United States, Pennsylvania|
|UPMC Cancer Centers Network|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Herb Zeh, M.D.||University of Pittsburgh|