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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00026130 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: fluorouracil Drug: gemcitabine hydrochloride Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma |
| Study Start Date: | September 2001 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed pancreatic adenocarcinoma
Non-metastatic disease that is unresectable due to any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Northeast Alabama Regional Medical Center | |
| Anniston, Alabama, United States, 36207 | |
| United States, California | |
| Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Naval Medical Center - San Diego | |
| San Diego, California, United States, 92134-3202 | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Veterans Affairs Medical Center - San Diego | |
| San Diego, California, United States, 92161 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Lombardi Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| Veterans Affairs Medical Center - Washington, DC | |
| Washington, District of Columbia, United States, 20422 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| United States, Florida | |
| Broward General Medical Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| Florida Hospital Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| Memorial Regional Cancer Center at Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| United States, Illinois | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615-7828 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| West Suburban Center for Cancer Care | |
| River Forest, Illinois, United States, 60305 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Fort Wayne Medical Oncology and Hematology, Incorporated | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| United States, Iowa | |
| Hematology Oncology Associates of the Quad Cities | |
| Bettendorf, Iowa, United States, 52722 | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kentucky | |
| Baptist Hospital East - Louisville | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Missouri Baptist Cancer Center | |
| Saint Louis, Missouri, United States, 63131 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | |
| Columbia, Missouri, United States, 65201 | |
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-7680 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| Veterans Affairs Medical Center - Las Vegas | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| New Hampshire Oncology-Hematology, PA - Hooksett | |
| Hooksett, New Hampshire, United States, 03106 | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cooper University Hospital | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| East Syracuse, New York, United States, 13057 | |
| Elmhurst Hospital Center | |
| Elmhurst, New York, United States, 11373 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Queens Cancer Center of Queens Hospital | |
| Jamaica, New York, United States, 11432 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| University Hospital at State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Veterans Affairs Medical Center - Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Veterans Affairs Medical Center - Syracuse | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Cape Fear Valley Health System | |
| Fayetteville, North Carolina, United States, 28302-2000 | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| FirstHealth Moore Regional Hospital | |
| Pinehurst, North Carolina, United States, 28374 | |
| Lenoir Memorial Hospital Cancer Center | |
| Kinston, North Carolina, United States, 28503-1678 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| NorthEast Oncology Associates - Concord | |
| Concord, North Carolina, United States, 28025 | |
| Veterans Affairs Medical Center - Asheville | |
| Asheville, North Carolina, United States, 28805 | |
| Veterans Affairs Medical Center - Durham | |
| Durham, North Carolina, United States, 27705 | |
| Zimmer Cancer Center at New Hanover Regional Medical Center | |
| Wilmington, North Carolina, United States, 28402-9025 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Rhode Island | |
| Lifespan: The Miriam Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Texas | |
| Veterans Affairs Medical Center - Dallas | |
| Dallas, Texas, United States, 75219 | |
| United States, Vermont | |
| Vermont Cancer Center at University of Vermont | |
| Burlington, Vermont, United States, 05401-3498 | |
| United States, Virginia | |
| Martha Jefferson Hospital | |
| Charlottesville, Virginia, United States, 22902 | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke | |
| Roanoke, Virginia, United States, 24014 | |
| Virginia Oncology Associates - Norfolk | |
| Norfolk, Virginia, United States, 23502 | |
| United States, West Virginia | |
| St. Mary's Medical Center | |
| Huntington, West Virginia, United States, 25701 | |
| Study Chair: | Harvey J. Mamon, MD, PhD | Dana-Farber/Brigham and Women's Cancer Center |
More Information
| Study ID Numbers: | CDR0000068988, CALGB-80003 |
| Study First Received: | November 9, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00026130 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Neoplasms by Site Therapeutic Uses Gemcitabine Endocrine Gland Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type |
Endocrine System Diseases Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Fluorouracil Pancreatic Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |