A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00336700|
Recruitment Status : Terminated (Study published November 2010 and no further work will be done)
First Posted : June 14, 2006
Results First Posted : September 19, 2016
Last Update Posted : September 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine Drug: Erlotinib||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||November 2011|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00336700
|United States, Pennsylvania|
|UPMC Cancer Centers Network|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Herb Zeh, M.D.||University of Pittsburgh|