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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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Martha Jefferson HospitalCharlottesville, Virginia  22901
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Mount Sinai Medical CenterNew York, New York  10029
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
NorthEast Oncology Associates - ConcordConcord, North Carolina  28025
Arthur G. James Cancer Hospital at Ohio State UniversityColumbus, Ohio  43210-1240
Oncology and Hematology Associates of Southwest Virginia, Incorporated - RoanokeRoanoke, Virginia  24014
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048
University Hospital at State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Brigham and Women's HospitalBoston, Massachusetts  02115
Memorial Regional Cancer Center at Memorial Regional HospitalHollywood, Florida  33021
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131