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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA031946 | U.S. NIH Grant/Contract | View source | |
| CLB-89805 | |||
| CDR0000066601 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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 gemcitabine plus radiation therapy in treating patients with pancreatic cancer that cannot be removed surgically.
OBJECTIVES: I. Estimate time to progression and overall survival of patients with locoregional adenocarcinoma of the pancreas treated with gemcitabine combined with radiation therapy. II. Estimate the biomarker response to this regimen through evaluation of circulating CA19-9 levels and correlate this response with survival of this patient population.
OUTLINE: Patients receive radiation therapy 5 days per week for 5 1/2 weeks and gemcitabine IV over 30 minutes not greater than 2 hours prior to radiation therapy twice weekly. This combination radiation therapy and chemotherapy is followed by 2 weeks of rest. Patients with stable or responding disease receive a higher dose of gemcitabine IV over 30 minutes weekly for 3 weeks followed by 1 week of rest. This 4 week course is repeated 3 more times for a total of 16 weeks of gemcitabine therapy alone. Patients are followed every 2 months for the first year and then every 3 months for the next 2 years or until disease progression. Upon documentation of disease progression, patients are followed every 3 months for survival and secondary malignancy.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gemcitabine + radiation | Experimental | Patients receive radiation therapy 5 days per week for 5 1/2 weeks and gemcitabine IV over 30 minutes not greater than 2 hours prior to radiation therapy twice weekly. This combination radiation therapy and chemotherapy is followed by 2 weeks of rest. Patients with stable or responding disease receive a higher dose of gemcitabine IV over 30 minutes weekly for 3 weeks followed by 1 week of rest. This 4 week course is repeated 3 more times for a total of 16 weeks of gemcitabine therapy alone. Patients are followed every 2 months for the first year and then every 3 months for the next 2 years or until disease progression. Upon documentation of disease progression, patients are followed every 3 months for survival and secondary malignancy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine hydrochloride | Drug | given IV |
| |
| radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | up to 3 years | |
| overall survival | up to 3 years |
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas Locoregional and not amenable to surgery based on 1 or more of the following: Size of pancreatic tumor greater than 5 cm Lymph nodes bulky, greater than 2 cm, but within radiation port Vascular involvement or impingement of major vessels (e.g., superior mesenteric artery, superior mesenteric vein, portal vein, hepatic artery) Involvement of colon (head lesions) or involvement of adrenal, kidney, or colon (tail lesions) Patients must be registered and begin treatment within 42 days of surgical staging No metastatic disease or nodal disease outside of radiation port documented by CT scan or MRI and chest x-ray
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Albumin greater than 3 g/dL Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL Calcium normal Other: No prior or concurrent malignancy within the past 5 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated cancers Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for carcinoma of the pancreas Chemotherapy: No prior chemotherapy for carcinoma of the pancreas No other concurrent chemotherapy Endocrine therapy: No prior endocrine therapy for carcinoma of the pancreas No concurrent hormone therapy (except for nondisease-related conditions) Radiotherapy: No prior radiation therapy for carcinoma of the pancreas No prior abdominal radiation therapy Surgery: See Disease Characteristics No prior surgery for carcinoma of the pancreas
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| Name | Affiliation | Role |
|---|---|---|
| Margaret A. Tempero, MD | University of California, San Francisco | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of California San Diego Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15361643 | Result | Blackstock AW, Tepper JE, Niedwiecki D, Hollis DR, Mayer RJ, Tempero MA. Cancer and leukemia group B (CALGB) 89805: phase II chemoradiation trial using gemcitabine in patients with locoregional adenocarcinoma of the pancreas. Int J Gastrointest Cancer. 2003;34(2-3):107-16. doi: 10.1385/ijgc:34:2-3:107. |
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| Radiation |
1.8 Gy to tumor bed |
|
| La Jolla |
| California |
| 92093-0658 |
| United States |
| UCSF Cancer Center and Cancer Research Institute | San Francisco | California | 94115-0128 | United States |
| Veterans Affairs Medical Center - San Francisco | San Francisco | California | 94121 | United States |
| CCOP - Christiana Care Health Services | Wilmington | Delaware | 19899 | United States |
| Vincent T. Lombardi Cancer Research Center, Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| University of Illinois at Chicago Health Sciences Center | Chicago | Illinois | 60612 | United States |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | 60612 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Veterans Affairs Medical Center - Togus | Togus | Maine | 04330 | United States |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri | 65201 | United States |
| Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | 65203 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Veterans Affairs Medical Center - Omaha | Omaha | Nebraska | 68105 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-3330 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Veterans Affairs Medical Center - Buffalo | Buffalo | New York | 14215 | 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 Presbyterian Hospital - Cornell Campus | New York | New York | 10021 | United States |
| Mount Sinai Medical Center, NY | New York | New York | 10029 | United States |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | 13210 | United States |
| 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 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | United States |
| Veterans Affairs Medical Center - Durham | Durham | North Carolina | 27705 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | 27104-4241 | United States |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157-1082 | United States |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus | Ohio | 43210 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| Veterans Affairs Medical Center - Memphis | Memphis | Tennessee | 38104 | United States |
| University of Tennessee, Memphis Cancer Center | Memphis | Tennessee | 38163 | United States |
| Vermont Cancer Center | Burlington | Vermont | 05401-3498 | United States |
| Veterans Affairs Medical Center - White River Junction | White River Junction | Vermont | 05009 | United States |
| Veterans Affairs Medical Center - Richmond | Richmond | Virginia | 23249 | United States |
| MBCCOP - Massey Cancer Center | Richmond | Virginia | 23298-0037 | 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 |
|---|---|
| D000093542 | Gemcitabine |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
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