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Pilot Trial of Capecitabine and Radiation Therapy With Pre and Post Combination Chemotherapy in Advanced Pancreatic Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Pilot Trial of Capecitabine and Radiation Therapy With Pre and Post Combination Chemotherapy in Advanced Pancreatic Cancer

Inclusion Criteria


Eligibility Criteria

1. Patients must have cytologic or histologic confirmation of pancreatic carcinoma.

2. Patients must have unresectable disease with or without distant metastases. A status
of unresectable will be based on review of helical CT scan and surgical consultation.

3. Patients with a history of previous abdominal irradiation or chemotherapy for
pancreatic cancer are ineligible.

4. Patients must have an estimated life expectancy of at least 12 weeks and a Zubrod
performance status of ≤ 2 (appendix I).

5. Patients must be 18 years of age or older. Patients with reproductive potential must
agree to use an effective contraceptive method during treatment.

6. Patients must have adequate organ function defined as follows: bone marrow -
granulocytes ≥ 1500/cmm, platelets > 100,000/cmm, renal – serum Cre < 1.5 mg/dl,
hepatic – bilirubin < 3 mg/dl.

7. Patients must be free of other active systemic malignancy or any other serious
co-morbid medical or psychiatric condition that would interfere with safe delivery of
protocol therapy.

8. Patients must be aware of the investigational nature of the therapy and provide
written informed consent as per institutional guidelines prior to the initiation of
treatment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mark Zalupski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 2001-046

NCT ID:

NCT00176735

Start Date:

December 2001

Completion Date:

August 2005

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

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