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Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Pancreatic Neoplasms

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Trial Information

Gemcitabine, Oxaliplatin and Radiation Therapy in Pancreatic Cancer

Inclusion Criteria:

- Patients must have cytologic or histologic confirmation of carcinoma arising in the

- 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

- 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 Criteria:

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of dose limiting toxicity up to three weeks following the second cycle of chemotherapy.

Principal Investigator

Mark Zalupski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

UMCC 2003-082



Start Date:

June 2004

Completion Date:

February 2010

Related Keywords:

  • Pancreatic Neoplasms
  • drug therapy
  • radiotherapy
  • clinical trial
  • Neoplasms
  • Pancreatic Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624