Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer
NCT ID: NCT00026130
Last Updated: 2016-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2001-09-30
2010-06-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer.
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Detailed Description
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* Determine the overall survival of patients with locally advanced non-metastatic pancreatic adenocarcinoma treated with gemcitabine, fluorouracil, and radiotherapy.
* Determine the time to progression in patients treated with this regimen.
* Determine the overall clinical response in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes once weekly and fluorouracil IV continuously on days 1-5 weekly for 6 weeks. Patients concurrently undergo radiotherapy 5 days a week for 6 weeks.
Three weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 24 months.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gemcitabine + 5FU + XRT
Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer
fluorouracil
200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6)
gemcitabine hydrochloride
200mg/sq m IV infusion over 30 min wkly (on d 1, 2, OR 3) during radiation tx (wks 1-6) 1000mg/sq m IV infusion over 30 min wkly for 3 weeks during ea chemotherapy cycle
radiation therapy
4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6)
Interventions
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fluorouracil
200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6)
gemcitabine hydrochloride
200mg/sq m IV infusion over 30 min wkly (on d 1, 2, OR 3) during radiation tx (wks 1-6) 1000mg/sq m IV infusion over 30 min wkly for 3 weeks during ea chemotherapy cycle
radiation therapy
4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed pancreatic adenocarcinoma
* Non-metastatic disease that is unresectable due to any of the following:
* Tumor greater than 5 cm
* Bulky lymph nodes greater than 2 cm, but within the radiation port
* Vascular involvement or impingement of major vessels
* Involvement of colon, adrenal glands, or kidney
* Measurable or evaluable disease
* No prior therapy for pancreatic adenocarcinoma
* No peritoneal seeding or other evidence of metastatic disease by laparotomy or laparoscopy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* CTC 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* AST no greater than 3 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Cardiovascular:
* No myocardial infarction within the past 6 months
Other:
* No other uncontrolled serious medical or psychiatric illness that would preclude study compliance
* No other malignancy within the past 5 years except limited or curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* No prior abdominal radiotherapy
Surgery:
* At least 2 weeks since prior major surgery
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Harvey J. Mamon, MD, PhD
Role: STUDY_CHAIR
Dana-Farber/Brigham and Women's Cancer Center
Locations
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Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
West Suburban Center for Cancer Care
River Forest, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Baptist Hospital East - Louisville
Louisville, Kentucky, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
University Hospital at State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
NorthEast Oncology Associates - Concord
Concord, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital at Ohio State University
Columbus, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Martha Jefferson Hospital
Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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References
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Mamon HJ, Niedzwiecki D, Hollis DR, et al.: Preliminary analysis of Cancer and Leukemia Group B (CALGB) 80003: a phase II trial of gemcitabine, 5-fluorouracil (5FU), and radiation therapy (RT) in locally advanced non-metastatic pancreatic adenocarcinoma. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-22, S13, 2005.
Other Identifiers
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CALGB-80003
Identifier Type: -
Identifier Source: secondary_id
CDR0000068988
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-80003
Identifier Type: -
Identifier Source: org_study_id
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