Capecitabine and Radiation Therapy in Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176735
• Other study ID #: UMCC 2001-046
• Status: Terminated
• Phase: N/A
• First received: September 9, 2005
• Last updated: May 18, 2015
• Start date: December 2001
• Est. completion date: August 2005

Study information

• Verified date: May 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: August 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Capecitabine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center