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Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Capecitabine
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Eligibility Criteria Patients must have cytologic or histologic confirmation of pancreatic carcinoma. 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. Patients with a history of previous abdominal irradiation or chemotherapy for pancreatic cancer are ineligible. Patients must have an estimated life expectancy of at least 12 weeks and a Zubrod performance status of ≤ 2 (appendix I). Patients must be 18 years of age or older. Patients with reproductive potential must agree to use an effective contraceptive method during treatment. 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. 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. 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    May 18, 2015
    Sponsor
    University of Michigan Rogel Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00176735
    Brief Title
    Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer
    Official Title
    Pilot Trial of Capecitabine and Radiation Therapy With Pre and Post Combination Chemotherapy in Advanced Pancreatic Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Michigan Rogel Cancer Center

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Capecitabine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Eligibility Criteria Patients must have cytologic or histologic confirmation of pancreatic carcinoma. 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. Patients with a history of previous abdominal irradiation or chemotherapy for pancreatic cancer are ineligible. Patients must have an estimated life expectancy of at least 12 weeks and a Zubrod performance status of ≤ 2 (appendix I). Patients must be 18 years of age or older. Patients with reproductive potential must agree to use an effective contraceptive method during treatment. 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. 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. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Zalupski, M.D.
    Organizational Affiliation
    University of Michigan Rogel Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer

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