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Phase II Chemoradiation Trial Using Gemcitabine in Patients With Locoregional Adenocarcinoma of the Pancreas


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Phase II Chemoradiation Trial Using Gemcitabine in Patients With Locoregional Adenocarcinoma of the Pancreas


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Principal Investigator

Margaret A. Tempero, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000066601

NCT ID:

NCT00003546

Start Date:

September 1998

Completion Date:

January 2006

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Dana-Farber Cancer Institute Boston, Massachusetts  02115
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Veterans Affairs Medical Center - Omaha Omaha, Nebraska  68105