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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
1500mg/m2 IV over 150 min IV q 2 weeks 4 months
150 mg/d Daily, oral 12 months
UPMC Cancer Centers Network
Pittsburgh, Pennsylvania, United States
Recurrence Free Survival (RFS)
The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.
Time frame: Up to 60 months
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 from from date of first study therapy to to death from any cause.
Time frame: Up to 60 months
Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
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).
Time frame: Up to 60 months
KRAS Mutational Status
KRAS mutation status in resected tumor specimens.
Time frame: Up to 60 months
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