Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

Completed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

Key facts

Study ID

NCT00456599

Run by

University of Michigan Rogel Cancer Center

People needed

71

Starts

2007-04-01

Expected to finish

2013-01-01

Last updated by the study team

2015-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
• Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
• Patients must have an expected 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, total 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 must be aware of the investigational nature of the therapy and provide written informed consent.
• Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
• Patients must not have used any investigational agent in the month before enrollment into the study.

You may not qualify if…

• Patients with neuroendocrine tumors are excluded.
• Patients with preexisting peripheral neuropathy > grade 2 are ineligible.
• Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Ohio State University — Columbus, Ohio, United States
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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