A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- Herbert J. Zeh, III MD, FACS
- Study ID
- NCT00336700
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Gemcitabine — DRUG1500mg/m2 IV over 150 min IV q 2 weeks 4 months
- Erlotinib — DRUG150 mg/d Daily, oral 12 months
Study Details
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.
Key Dates
- First listed
- Jun 14, 2006
- Start date
- Jun 30, 2006
- Status verified
- Jul 2016
- Primary completion
- Oct 31, 2011
- Completion
- Nov 30, 2011
Study Design
- Enrollment
- 25 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Gemcitabine and ErlotinibErlotinib (oral) 150 mg/day x 12 months Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months
Primary Outcome Measure
Recurrence Free Survival (RFS) [ Time Frame: Up to 60 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UPMC Cancer Centers Network | Pittsburgh | Pennsylvania | 15232 | - |
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