Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT00176735
• Recruitment Status: Terminated
• First Posted: September 15, 2005
• Last Update Posted: May 20, 2015
• Sponsor: University of Michigan Rogel Cancer Center
• Information provided by: University of Michigan Rogel Cancer Center

Tracking Information

• First Submitted Date: September 9, 2005
• First Posted Date: September 15, 2005
• Last Update Posted Date: May 20, 2015
• Study Start Date: December 2001
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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

Recruitment Information

• Recruitment Status: Terminated
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: August 2005
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00176735
• Other Study ID Numbers: UMCC 2001-046
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mark Zalupski, M.D.; University of Michigan Rogel Cancer Center

• PRS Account: University of Michigan Rogel Cancer Center
• Verification Date: May 2015