Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of gemcitabine plus radiation therapy in treating patients with pancreatic cancer that can not be surgically removed.
Drug: gemcitabine hydrochloride
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Trial of Combined Modality Gemcitabine Plus Radiation Therapy for Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma|
|Study Start Date:||April 1998|
|Study Completion Date:||March 2002|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine in combination with radiation therapy to patients with locally advanced and/or unresectable adenocarcinoma of the pancreas. II. Determine the dose limiting toxic effects of this combination therapy in these patients. III. Evaluate the ability of these patients to tolerate induction and then maintenance therapy with gemcitabine preceding and following combination therapy. IV. Evaluate the efficacy (response rate, pattern of failure, and survival) of this combination therapy in these patients.
OUTLINE: This is a dose escalation study of gemcitabine. Part I: Patients receive gemcitabine as a continuous infusion over 30 minutes once weekly for 3 weeks followed by 1 week of rest. Part II: Gemcitabine IV is administered as a 30 minute infusion twice a week (Monday and Thursday) for 5-6 weeks. Patients receive radiation therapy 5 days a week for 5-6 weeks. In the absence of dose-limiting toxicity (DLT) in the first 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of gemcitabine on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Part III: In the absence of toxicity and disease progression, patients continue gemcitabine for 3 additional courses. Maintenance gemcitabine starts 4 weeks after the completion of radiation therapy and is administered once weekly for 3 weeks followed by 1 week of rest. Patients are followed until death.
PROJECTED ACCRUAL: This study will accrue 15-30 patients in approximately 24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003426
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David Paul Kelsen, MD||Memorial Sloan Kettering Cancer Center.|