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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CALGB-80003 | |||
| CDR0000068988 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine + 5FU + XRT | Experimental | Chemo and radiation therapy in the treatment of non-metastatic pancreatic cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorouracil | Drug | 200mg/sq m/d CIVI 5/7 days during radiation therapy (wks 1-6) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 9 months up to 3 years post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | After 2 cycles of tx, then q 2 mon for 1 yr then q 3 mon for 2 yrs | |
| Clinical Response | q 2 mon for Yr 1 post Tx, then q 3 mon for 2 yrs | |
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DISEASE CHARACTERISTICS:
Histologically confirmed pancreatic adenocarcinoma
Non-metastatic disease that is unresectable due to any of the following:
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Harvey J. Mamon, MD, PhD | Dana-Farber/Brigham and Women's Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Alabama Regional Medical Center | Anniston | Alabama | 36207 | United States | ||
| Rebecca and John Moores UCSD Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
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| gemcitabine hydrochloride | Drug | 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 | Radiation | 4500cGy total in 25 fractions M-F followed by 540cGy in 3 fractions (Total dose 5040cGy)during radiation tx (wks 1-6) |
|
| CA19-9 Levels |
Biomarker response |
| q cycle, then q 2 mon for 1 yr, then q 3 mon for 2 yrs |
| Toxicity | q cycle |
| La Jolla |
| California |
| 92093-0658 |
| United States |
| Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Naval Medical Center - San Diego | San Diego | California | 92134-3202 | United States |
| Veterans Affairs Medical Center - San Diego | San Diego | California | 92161 | United States |
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Veterans Affairs Medical Center - San Francisco | San Francisco | California | 94121 | United States |
| CCOP - Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Lombardi Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5001 | United States |
| Veterans Affairs Medical Center - Washington, DC | Washington D.C. | District of Columbia | 20422 | United States |
| Broward General Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Memorial Regional Cancer Center at Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | United States |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | 60612 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Louis A. Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615-7828 | United States |
| West Suburban Center for Cancer Care | River Forest | Illinois | 60305 | United States |
| Fort Wayne Medical Oncology and Hematology, Incorporated | Fort Wayne | Indiana | 46885-5099 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Hematology Oncology Associates of the Quad Cities | Bettendorf | Iowa | 52722 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1009 | United States |
| Baptist Hospital East - Louisville | Louisville | Kentucky | 40207 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| UMASS Memorial Cancer Center - University Campus | Worcester | Massachusetts | 01655 | United States |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| University of Minnesota Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri | 65201 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | United States |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Veterans Affairs Medical Center - Las Vegas | Las Vegas | Nevada | 89106 | United States |
| New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett | New Hampshire | 03106 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Veterans Affairs Medical Center - Buffalo | Buffalo | New York | 14215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | East Syracuse | New York | 13057 | United States |
| Elmhurst Hospital Center | Elmhurst | New York | 11373 | United States |
| Queens Cancer Center of Queens Hospital | Jamaica | New York | 11432 | United States |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| New York Weill Cornell Cancer Center at Cornell University | New York | New York | 10021 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| University Hospital at State University of New York - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Veterans Affairs Medical Center - Syracuse | Syracuse | New York | 13210 | United States |
| Veterans Affairs Medical Center - Asheville | Asheville | North Carolina | 28805 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| NorthEast Oncology Associates - Concord | Concord | North Carolina | 28025 | United States |
| Veterans Affairs Medical Center - Durham | Durham | North Carolina | 27705 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Cape Fear Valley Health System | Fayetteville | North Carolina | 28302-2000 | United States |
| CCOP - Southeast Cancer Control Consortium | Goldsboro | North Carolina | 27534-9479 | United States |
| Lenoir Memorial Hospital Cancer Center | Kinston | North Carolina | 28503-1678 | United States |
| FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | 28374 | United States |
| Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington | North Carolina | 28402-9025 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | United States |
| Arthur G. James Cancer Hospital at Ohio State University | Columbus | Ohio | 43210-1240 | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
| Lifespan: The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Veterans Affairs Medical Center - Dallas | Dallas | Texas | 75219 | United States |
| Vermont Cancer Center at University of Vermont | Burlington | Vermont | 05401-3498 | United States |
| Martha Jefferson Hospital | Charlottesville | Virginia | 22902 | United States |
| Virginia Oncology Associates - Norfolk | Norfolk | Virginia | 23502 | United States |
| MBCCOP - Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke | Roanoke | Virginia | 24014 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25701 | United States |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000093542 | Gemcitabine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D013812 | Therapeutics |
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