Status:
COMPLETED
Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Sanofi-Synthelabo
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study will examine a proposed research treatment which evaluates the addition of oxaliplatin, a chemotherapy agent, to gemcitabine, another chemotherapy agent, and radiation therapy for the treat...
Eligibility Criteria
Inclusion
- Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
- Patients may have any stage of pancreatic cancer but if metastatic, systemic disease burden should be asymptomatic and small in volume.
- Determination of resectability must be made prior to registration.
- Patients must have an estimated life expectancy of at least 12 weeks and a Zubrod performance status of \< = 2.
- Patients must have adequate organ function defined as follows: absolute neutrophil count of \> = 1500/mm3, platelets \> = 100,000/mm3, serum Cr \< = 1.5 mg/dl, bilirubin \< 3.0 mg/dl, with relief of biliary obstruction if present (PTC tube or endobiliary stent).
- Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
- Patients of reproductive potential must have agreed to use an effective contraceptive method during participation in this trial and for 6 months after trial.
- Patient must be aware of the investigational nature of the therapy and provide written informed consent.
Exclusion
- Patients with neuroendocrine tumors are excluded.
- Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
- Patient must not have used any investigational agent in the month before enrollment into the study.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00242190
Start Date
June 1 2004
End Date
February 1 2010
Last Update
November 15 2010
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109