Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer

NCT ID: NCT00176735

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2005-08-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Capecitabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Mark Zalupski, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Other Identifiers

UMCC 2001-046

Identifier Type: -

Identifier Source: org_study_id