A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
|Study Design:||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|
- Recurrence Free Survival (RFS) [ Time Frame: Up to 60 months ]The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.
- 1-year Recurrence Free Survival (RFS) [ Time Frame: Up to 60 months ]
- 2-year Recurrence Free Survival (RFS) [ Time Frame: Up to 60 months ]
- Estimated 1&2 Year Overall Survival (OS) [ Time Frame: Up to 60 months ]Time from from date of first study therapy to to death from any cause.
- Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR) [ Time Frame: Up to 60 months ]Percentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC).
- KRAS Mutational Status [ Time Frame: Up to 60 months ]KRAS mutation status in resected tumor specimens.
|Study Start Date:||June 2006|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336700
|United States, Pennsylvania|
|UPMC Cancer Centers Network|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Herb Zeh, M.D.||University of Pittsburgh|