Clinical trial NCT00003546: Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer
Official title: Phase II Chemoradiation Trial Using Gemcitabine in Patients With Locoregional Adenocarcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-09-13
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

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

Primary outcomes:
measure: progression free survival
timeFrame: up to 3 years
measure: overall survival
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Veterans Affairs Medical Center - Birmingham
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center and Cancer Research Institute
state: California
city: San Francisco
country: United States
facility: Veterans Affairs Medical Center - San Francisco
state: California
city: Wilmington
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Vincent T. Lombardi Cancer Research Center, Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Miami Beach
country: United States
facility: CCOP - Mount Sinai Medical Center
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago Health Sciences Center
state: Illinois
city: Chicago
country: United States
facility: Veterans Affairs Medical Center - Chicago (Westside Hospital)
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Togus
country: United States
facility: Veterans Affairs Medical Center - Togus
state: Maine
city: Baltimore
country: United States
facility: Marlene & Stewart Greenebaum Cancer Center, University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Veterans Affairs Medical Center - Minneapolis
state: Minnesota
city: Columbia
country: United States
facility: Veterans Affairs Medical Center - Columbia (Truman Memorial)
state: Missouri
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center - Columbia
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Omaha
country: United States
facility: Veterans Affairs Medical Center - Omaha
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: CCOP - Southern Nevada Cancer Research Foundation
state: Nevada
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: Buffalo
country: United States
facility: Veterans Affairs Medical Center - Buffalo
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell Campus
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center, NY
state: New York
city: Syracuse
country: United States
facility: CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
state: New York
city: Syracuse
country: United States
facility: State University of New York - Upstate Medical University
state: New York
city: Syracuse
country: United States
facility: Veterans Affairs Medical Center - Syracuse
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Durham
country: United States
facility: Veterans Affairs Medical Center - Durham
state: North Carolina
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital - Ohio State University
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Veterans Affairs Medical Center - Memphis
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee, Memphis Cancer Center
state: Tennessee
city: Burlington
country: United States
facility: Vermont Cancer Center
state: Vermont
city: White River Junction
country: United States
facility: Veterans Affairs Medical Center - White River Junction
state: Vermont
city: Richmond
country: United States
facility: Veterans Affairs Medical Center - Richmond
state: Virginia
city: Richmond
country: United States
facility: MBCCOP - Massey Cancer Center
state: Virginia
Study officials:
affiliation: University of California, San Francisco
name: Margaret A. Tempero, MD
role: STUDY_CHAIR
References:
citation: 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.