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.

Condition	Treatment or Intervention	Phase
stage III pancreatic cancer adenocarcinoma of the pancreas stage I pancreatic cancer stage II pancreatic cancer	Drug: gemcitabine	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

Alabama
      Veterans Affairs Medical Center - Birmingham, Birmingham,  Alabama,  35233,  United States
California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94115-0128,  United States
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States
      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington,  District of Columbia,  20007,  United States
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States
Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  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
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States
Maine
      Veterans Affairs Medical Center - Togus, Togus,  Maine,  04330,  United States
Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States
Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Minnesota
      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States
Missouri
      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia,  Missouri,  65201,  United States
Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States
      Veterans Affairs Medical Center - Omaha, Omaha,  Nebraska,  68105,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States
New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse,  New York,  13210,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States
      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States
      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States
      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States
North Carolina
      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
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  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
Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States
Tennessee
      University of Tennessee, Memphis Cancer Center, Memphis,  Tennessee,  38163,  United States
      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States
Vermont
      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States
      Veterans Affairs Medical Center - White River Junction, White River Junction,  Vermont,  05009,  United States
Virginia
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States
      Veterans Affairs Medical Center - Richmond, Richmond,  Virginia,  23249,  United States

Study chairs or principal investigators

Margaret Ann Tempero,  Study Chair,  Cancer and Leukemia Group B   

Study ID Numbers:  CDR0000066601; CLB-89805
Record last reviewed:  February 2005
Last Updated:  February 8, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003546
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08