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Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole Versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole Versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer


OBJECTIVES: I. Compare overall and disease free survival in patients with completely
resected stage II or III colon cancer randomized to adjuvant chemotherapy with bolus
fluorouracil and leucovorin calcium with levamisole vs continuous infusion fluorouracil with
levamisole.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, T stage (T1 vs T2 vs T3 vs T4a), N stage (N0 vs N1 vs N2-3), and time from surgery
until registration (21-28 vs 29-35 days). Patients are randomized to one of two treatment
arms. Arm I: Patients receive leucovorin calcium IV immediately followed by fluorouracil IV
on days 1 through 5 of weeks 1, 5, 9, 14, 19, and 24, and oral levamisole 3 times a day for
3 days on days 1-3. Courses repeat every 2 weeks for 6 months. Arm II: Patients receive
levamisole as in arm I plus fluorouracil by continuous IV infusion for 8 weeks. Treatment
with fluorouracil repeats every 10 weeks for 3 courses. Treatment continues in the absence
of disease progression or unacceptable toxicity. Patients are followed at 9 months and 12
months, then every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for the study over
approximately 5.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven resectable stage II or III adenocarcinoma
of the colon Caudal margin of the primary tumor must lie above the peritoneal reflection
Must have pathologic confirmation of either N1-3 (stage III), or if N0, must have T3-T4
(stage II) with bowel obstruction or perforation Obstruction documented as: At least 75%
colon or small bowel obstruction on x-ray and/or endoscopy Significant bowel dilatation
surgically documented Significant obstruction described in the pathology report
Perforation documented by gross operative/pathologic evidence of a colon wall defect with
associated abscess or peritonitis Complete en bloc resection by laparotomy required No
laparoscopic colectomy without prior surgery on protocol SWOG-9411 No gross or microscopic
residual disease No distant peritoneal metastases (stage IV) even if grossly resectable No
requirement to open the pelvic peritoneum to define the extent of disease No extrapelvic
nodal metastasis unless resected en bloc with the primary tumor No distant metastases No
other diagnosis of stage II-III colon cancer within the past 5 years May have undergone
complete surgical resection at least 5 years prior to study Completely resected prior or
synchronous stage 0-I colon cancer eligible

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Hematopoietic: WBC (white
blood cell) at least 3,500/mm3 Platelet count at least within the lower limit of normal
Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST (angiotensin
sensitivity test) no greater than 2 times ULN Alkaline phosphatase no greater than 2
times ULN Renal: Creatinine no greater than 2 times ULN Other: No organic brain syndrome,
Alzheimer's disease, or other altered mental status No second malignancy within 5 years
except: Adequately treated nonmelanomatous skin cancer Adequately treated carcinoma in
situ of the cervix Not pregnant or nursing Negative pregnancy test Effective contraception
required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
fluorouracil or other chemotherapy for cancer No concurrent chemotherapy Endocrine
therapy: Not specified Radiotherapy: No prior or concurrent radiotherapy for cancer
Surgery: Complete en bloc resection required (see Disease Characteristics)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare effectiveness of bolus 5-FU, leucovorin, levamisole vs continuous infusion 5-FU, levamisole as adjuvant therapy for patients with colon cancer, measured in overall survival

Outcome Time Frame:

At death

Safety Issue:

No

Principal Investigator

Elizabeth A. Poplin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000063773

NCT ID:

NCT00002593

Start Date:

December 1994

Completion Date:

March 2005

Related Keywords:

  • Colorectal Cancer
  • stage II colon cancer
  • stage III colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Emory University Hospital - AtlantaAtlanta, Georgia  30322
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Rochester Cancer CenterRochester, New York  14642
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Ireland Cancer CenterCleveland, Ohio  44106-5065
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Barnes-Jewish HospitalSaint Louis, Missouri  63110
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
Mount Sinai Medical Center, NYNew York, New York  10029
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
CentraCare ClinicSaint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Medical College of WisconsinMilwaukee, Wisconsin  53226
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
Veterans Affairs Medical Center - Chicago (Lakeside)Chicago, Illinois  60611
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304