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A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma


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

Thank you

Trial Information

A Phase II Trial of Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-Metastatic Pancreatic Adenocarcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

9 months up to 3 years post treatment

Safety Issue:

No

Principal Investigator

Harvey J. Mamon, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068988

NCT ID:

NCT00026130

Start Date:

September 2001

Completion Date:

June 2010

Related Keywords:

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

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Duke Comprehensive Cancer Center Durham, North Carolina  27710
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Martha Jefferson Hospital Charlottesville, Virginia  22901
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Naval Medical Center - San Diego San Diego, California  92134-3202
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
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
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Broward General Medical Center Fort Lauderdale, Florida  33316
Florida Hospital Cancer Institute Orlando, Florida  32804
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
Veterans Affairs Medical Center - San Diego San Diego, California  92161
UCSF Comprehensive Cancer Center San Francisco, California  94115
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Cooper University Hospital Camden, New Jersey  08103
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
Cape Fear Valley Health System Fayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer Center Kinston, North Carolina  28503-1678
FirstHealth Moore Regional Hospital Pinehurst, North Carolina  28374
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Mount Sinai Medical Center New York, New York  10029
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - Hooksett Hooksett, New Hampshire  03106
NorthEast Oncology Associates - Concord Concord, North Carolina  28025
Arthur G. James Cancer Hospital at Ohio State University Columbus, Ohio  43210-1240
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke Roanoke, Virginia  24014
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph Saint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Zimmer Cancer Center at New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles, California  90048
University Hospital at State University of New York - Upstate Medical University Syracuse, New York  13210
Brigham and Women's Hospital Boston, Massachusetts  02115
Memorial Regional Cancer Center at Memorial Regional Hospital Hollywood, Florida  33021
Missouri Baptist Cancer Center St. Louis, Missouri  63131