Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Non-Metastatic Pancreatic Cancer
A Phase I Study of Gemcitabine, 5-Fluorouracil, and Radiation Therapy in the Treatment of Locally Unresectable Non-Metastatic Pancreatic Cancer
1 other identifier
interventional
40
1 country
3
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 pancreatic-cancer
Started Jan 1998
Longer than P75 for phase_1 pancreatic-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 8, 2005
CompletedFirst Posted
Study publicly available on registry
November 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedDecember 20, 2016
December 1, 2016
9.4 years
November 8, 2005
December 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the maximum tolerated dose of weekly gemcitabine when administered with continuous infusion 5-fluorouracil and external beam radiation.
phase 1
Secondary Outcomes (2)
To determine the safety if this regimen
phase 1
to obtain a preliminary assessment of the efficacy of this regimen in this patient population.
phase 1
Study Arms (1)
5-FU/gemcitabine/RT
EXPERIMENTALInterventions
Gemcitabine, IV bolus administered weekly (weeks 1-6) at least 4 hours before that day's radiation therapy.
External Beam Radiotherapy (weeks 1-6), Monday through Friday.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles S. Fuchs, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 8, 2005
First Posted
November 10, 2005
Study Start
January 1, 1998
Primary Completion
June 1, 2007
Study Completion
August 1, 2008
Last Updated
December 20, 2016
Record last verified: 2016-12