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

Completed · Phase 1

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00251355

Run by

Dana-Farber Cancer Institute

People needed

40

Starts

1998-01-01

Expected to finish

2008-08-01

Last updated by the study team

2016-12-20

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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