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Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer



Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer

For Condition: adenocarcinoma of the pancreas,stage 2 pancreatic cancer,stage 3 pancreatic cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven locally advanced and/or unresectable adenocarcinoma of the pancreas - No metastatic disease - No completely resected pancreatic cancer --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior gemcitabine; No prior chemotherapy for pancreatic cancer - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to the pancreas - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% OR ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 2.0 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No congestive heart failure; No New York Heart Association class III and IV heart disease - Other: Not pregnant; No concurrent medical problems that would increase the side effects or morbidity of chemoradiation; No concurrent medical condition that would make patient ineligible to receive external beam radiation such as: Crohn's disease; Inflammatory bowel disease; No active infection requiring systemic antibiotics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DavidKelsen,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  CDR0000066451;  MSKCC-98019,NCI-H98-0020
Study Start Date: April 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003426

Other Adenocarcinoma Of The Pancreas Studies:
1. Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

2. Combination Chemotherapy Plus Radiation Therapy With or Without Tipifarnib in Treating Patients With Locally Advanced Pancreatic Cancer

3. Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas

4. Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer

5. Gemcitabine With or Without Pemetrexed Disodium in Treating Patients With Unresectable Stage II, Stage III, or Stage IV Pancreatic Cancer

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