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Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176735
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : May 20, 2015
Information provided by:
University of Michigan Rogel Cancer Center

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date May 20, 2015
Study Start Date  ICMJE December 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer
Official Title  ICMJE Pilot Trial of Capecitabine and Radiation Therapy With Pre and Post Combination Chemotherapy in Advanced Pancreatic Cancer
Brief Summary

Pancreatic cancer has traditionally been treated with chemotherapy and radiation therapy with limited results. Preliminary studies of parts of this program in patients with advanced pancreatic cancer have produced favorable results with acceptable side effects. We feel that this treatment sequence may help to slow and/or control the growth of pancreatic cancer.

This study will help doctors learn whether pancreatic cancer will respond to this treatment. This study will use the combination of two chemotherapy drugs, gemcitabine and cisplatin, before and after treatment with radiation therapy and an oral chemotherapy drug called capecitabine. This sequence of combination chemotherapy before and after radiation therapy, and radiation therapy with the drug capecitabine is what is under study. Parts of this sequence, for example, the combination of gemcitabine and cisplatin, have shown promising results in the treatment of pancreatic cancer. This research study is an attempt to combine these various parts.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Drug: Capecitabine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00176735
Other Study ID Numbers  ICMJE UMCC 2001-046
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Michigan Rogel Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Zalupski, M.D. University of Michigan Rogel Cancer Center
PRS Account University of Michigan Rogel Cancer Center
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP