Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test a new treatment of pancreatic cancer that cannot be removed by surgery. This treatment is a Phase I dose escalation research study which will combine one drug at increasing doses with a fixed dose of a second drug and radiation therapy. The drug that will be used at increasing doses is gemcitabine whereas 5-fluorouracil will remain the same for all patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Fluorouracil; Gemcitabine

Criteria

Inclusion Criteria:

• Histologic confirmation of locally unresectable pancreatic adenocarcinoma. Patients with either measurable of evaluable disease are eligible.

• Unresectable, non-metastatic tumors. Unresectable patients include those with local extension of the tumor into adjacent structures and/or nodal metastasis.

• Total bilirubin < 2.0 mg/dl

• AST < 3x ULN

• Serum creatinine < 2.0 mg/dl

• WBC > 3,000/mm3

• Platelets > 100,000/mm3

• ECOG performance status < or = to 2

• Life expectancy of greater than 12 weeks

Exclusion Criteria:

• Evidence of peritoneal seeding by malignancy

• Prior radiation therapy or chemotherapy for pancreatic cancer

• Myocardial infarction in the past 6 months

• Major surgery in past two weeks

• Uncontrolled serious medical or psychiatric illness

• Pregnant or lactating women

• Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.