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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer

Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer



Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer

For Condition: stage 2 pancreatic cancer,stage 3 pancreatic cancer,adenocarcinoma of the pancreas
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: 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 advancedpancreatic cancer.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
HarveyMamon,  Study Chair,  Brigham and Women's Hospital

Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica,  New York,  11432
United States
Recruiting Hans  Grunwald 718-883-4118

Mount Sinai Medical Center, NY *Recruiting*
New York City,  New York,  10029
United States
Recruiting Lewis  Silverman 212-241-5520

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting Charles  Fuchs 617-632-5840

Veterans Affairs Medical Center - White River Junction *Recruiting*
White River Junction,  Vermont,  05009
United States
Recruiting Joseph  O'Donnell 802-295-9363 ext. 5480

St. Mary's Medical Center *Recruiting*
Huntington,  West Virginia,  25701
United States
Recruiting Gerrit  Kimmey 304-528-4645

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem,  North Carolina,  27157-1082
United States
Recruiting David  Hurd 336-716-2088

Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon,  New Hampshire,  03756-0002
United States
Recruiting Marc  Ernstoff 603-650-5534

University of Puerto Rico School of Medicine Medical Sciences Campus *Recruiting*
San Juan,  ,  00936-5067
Puerto Rico
Recruiting Enrique  Velez-Garcia 787-754-0101 Ext.2020

New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett,  New Hampshire,  03106
United States
Recruiting Douglas  Weckstein 603-622-6484

West Suburban Center for Cancer Care *Recruiting*
River Forest,  Illinois,  60305
United States
Recruiting John  Showel 708-763-2700

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

Western Pennsylvania Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15224
United States
Recruiting Richard  Shadduck 412-578-4355

UCSF Comprehensive Cancer Center *Recruiting*
San Francisco,  California,  94115
United States
Recruiting Alan  Venook 800-888-8664

CCOP - Mount Sinai Medical Center *Recruiting*
Miami,  Florida,  33140
United States
Recruiting Rogerio  Lilenbaum 305-674-2625

Baptist Hospital East - Louisville *Recruiting*
Louisville,  Kentucky,  40207
United States
Recruiting Daniel  Scullin 502-897-1166

Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City,  Iowa,  52242-1009
United States
Recruiting Gerald  Clamon 319-356-1932

Missouri Baptist Cancer Center *Recruiting*
St. Louis,  Missouri,  63131
United States
Recruiting Alan  Lyss 314-996-5514

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Bruce  Peterson 612-624-5631

MBCCOP - Massey Cancer Center *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting John  Roberts 804-828-0450

Barnes-Jewish Hospital *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Nancy  Bartlett 314-747-3000

Northeast Alabama Regional Medical Center *Recruiting*
Anniston,  Alabama,  36207
United States
Recruiting Thomas  Twele 256-236-2549

Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego,  California,  92161
United States
Recruiting Saeeda  Kirmani 619-552-8585 ext. 3356

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco,  California,  94121
United States
Recruiting Patricia  Cornett 415-221-4810 ext. 3423

Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C.,  District of Columbia,  20422
United States
Recruiting Steven  Krasnow 202-745-8178

Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla,  California,  92093-0658
United States
Recruiting Stephen  Seagren 858-657-7020

Walter Reed Army Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20307-5000
United States
Recruiting Joseph  Drabick 202-782-6751

Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne,  Indiana,  46885-5099
United States
Recruiting Sreenivasa  Nattam 219-484-8830

CCOP - North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Vincent  Vinciguerra 516-562-8915

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph,  Michigan,  49085
United States
Recruiting Eric  Lester 269-982-4963

Cape Fear Valley Health System *Recruiting*
Fayetteville,  North Carolina,  28302-2000
United States
Recruiting Kamal  Bakri 910-609-6910

Hematology Oncology Associates of the Quad Cities *Recruiting*
Bettendorf,  Iowa,  52722
United States
Recruiting S.  Zaentz 563-355-7733

Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas,  Nevada,  89106
United States
Recruiting Chitha  Hulugalle 702-696-3000

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting Karen  Wendling 773-834-7424

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Clifford  Hudis 212-639-6483

Vermont Cancer Center at University of Vermont *Recruiting*
Burlington,  Vermont,  05401-3498
United States
Recruiting Hyman  Muss 802-847-3827

Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus,  Ohio,  43210-1240
United States
Recruiting Clara  Bloomfield 614-293-7518

Lifespan: The Miriam Hospital *Recruiting*
Providence,  Rhode Island,  02906
United States
Recruiting William  Sikov 401-793-7151

Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis,  Minnesota,  55417
United States
Recruiting Vicki  Morrison 612-725-2000 ext. 4135

NorthEast Oncology Associates *Recruiting*
Concord,  North Carolina,  28025
United States
Recruiting James  Wall 704-783-1370

Veterans Affairs Medical Center - Columbia (Truman Memorial) *Recruiting*
Columbia,  Missouri,  65201
United States
Recruiting William  Patterson 573-882-6163

Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore,  Maryland,  21201
United States
Recruiting Martin  Edelman 410-328-2703

Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20007
United States
Recruiting Edward  Gelmann 202-444-7303

New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City,  New York,  10021
United States
Recruiting Scott  Wadler 212-746-2844

Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk,  Virginia,  23502
United States
Recruiting Paul  Conkling 757-466-8683

Brigham and Women's Hospital *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting Harvey  Mamon 617-732-7906

Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville,  North Carolina,  28805
United States
Recruiting John  Lucke 828-299-2540

Veterans Affairs Medical Center - Buffalo *Recruiting*
Buffalo,  New York,  14215
United States
Recruiting Lynn  Steinbrenner 716-862-3191

Broward General Medical Center *Recruiting*
Ft. Lauderdale,  Florida,  33316
United States
Recruiting Luis  Barreras 954-771-0692

Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia,  Missouri,  65203
United States
Recruiting Michael  Perry 573-882-4979

Palm Beach Cancer Institute *Recruiting*
West Palm Beach,  Florida,  33401
United States
Recruiting Robert  Jacobson 561-366-4150

Martha Jefferson Hospital *Recruiting*
Charlottesville,  Virginia,  22902
United States
Recruiting Stefan  Gorsch 434-982-8410

Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood,  Florida,  33021
United States
Recruiting Atif  Hussein 954-986-6363

Roswell Park Cancer Institute *Recruiting*
Buffalo,  New York,  14263-0001
United States
Recruiting Ellis  Levine 716-845-8547

Veterans Affairs Medical Center - Durham *Recruiting*
Durham,  North Carolina,  27705
United States
Recruiting Michael  Kelley 919-286-0411

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles,  California,  90048
United States
Recruiting Alan  Lefor 310-423-5874

Veterans Affairs Medical Center - Syracuse *Recruiting*
Syracuse,  New York,  13210
United States
Recruiting Stephen  Graziano 315-476-7461

UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha,  Nebraska,  68198-7680
United States
Recruiting Margaret  Kessinger 402-559-7511

Florida Hospital Cancer Institute *Recruiting*
Orlando,  Florida,  32804
United States
Recruiting Jane  Crofton 407-303-2090

Elmhurst Hospital Center *Recruiting*
Elmhurst,  New York,  11373
United States
Recruiting Vladimir  Benisovich 718-334-3723

Green Mountain Oncology Group *Recruiting*
Bennington,  Vermont,  05201
United States
Recruiting L.  Maurer 802-442-1290

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599-7295
United States
Recruiting Thomas  Shea 919-966-7746

CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend,  Indiana,  46601
United States
Recruiting Rafat  Ansari 574-284-7977

Saint Anthony Medical Center *Recruiting*
Rockford,  Illinois,  61108
United States
Recruiting Richard  Nora 815-227-2273

Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75216
United States
Recruiting Barry  Levinson 214-648-4193

North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Daniel  Budman 516-562-8958

Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke,  Virginia,  24014
United States
Recruiting Paul  Richards 540-982-0237

CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas,  Nevada,  89106
United States
Recruiting John  Ellerton 702-384-0013

University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse,  New York,  13210
United States
Recruiting Stephen  Graziano 315-464-8200

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-271-4022

Cooper University Hospital *Recruiting*
Camden,  New Jersey,  08103
United States
Recruiting Edison  Catalano 856-342-2506

Lenoir Memorial Hospital Cancer Center *Recruiting*
Kinston,  North Carolina,  28503-1678
United States
Recruiting Peter  Watson 919-559-2200 Ext. 201

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse,  New York,  13217
United States
Recruiting Jeffrey  Kirshner 315-472-7504

Duke Comprehensive Cancer Center *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Jeffrey  Crawford 919-684-5195

New Hanover Regional Medical Center *Recruiting*
Wilmington,  North Carolina,  28402-9025
United States
Recruiting Cyrus  Kotwall 910-763-4630

University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester,  Massachusetts,  01655
United States
Recruiting Pankaj  Bhargava 508-856-6884

FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst,  North Carolina,  28374
United States
Recruiting Ellen  Willard 910-295-9205

Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Thomas  Lad 312-996-2046

CCOP - Illinois Oncology Research Association *Recruiting*
Peoria,  Illinois,  61602
United States
Recruiting John  Kugler 309-636-3605

Louis A. Weiss Memorial Hospital *Recruiting*
Chicago,  Illinois,  60640
United States
Recruiting Keith  Shulman 773-564-5022


Additional Information:
Study ID Numbers:
  CDR0000068988;  CALGB-80003
Study Start Date: 
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026130

Other Stage 3 Pancreatic Cancer Studies:
1. Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas

2. Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas

3. Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

4. Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic Cancer

5. Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer

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Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer

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