Status:
COMPLETED
Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-72 years
Phase:
PHASE1
Brief 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 i...
Detailed Description
* Ultimately we plan to find the maximum tolerated dose of the combination of gemcitabine, 5-fluorouracil and radiation therapy. We also hope to assess the number of people who respond to this therapy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00251355
Start Date
January 1 1998
End Date
August 1 2008
Last Update
December 20 2016
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115