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S9415 Chemotherapy in Patients With Stage II or III Colon Cancer That Has Been Surgically Removed

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00002593
Collaborator
National Cancer Institute (NCI) (NIH), Cancer and Leukemia Group B (Other), Eastern Cooperative Oncology Group (Other), North Central Cancer Treatment Group (Other)
1,135
Enrollment
60
Locations
2
Arms
123
Duration (Months)
18.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given in different ways in treating patients with surgically removed stage II or stage III colon cancer at high risk of recurrence.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole Versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer
Study Start Date :
Dec 1, 1994
Actual Primary Completion Date :
Dec 1, 1999
Actual Study Completion Date :
Mar 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 5-FU/Leucovorin/Levamisole

levamisole hydrochloride: 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; leucovorin calcium: 20 mg/m^2/day, IV, Days 1-5 of each cycle; 5-fluorouracil: 425 mg/m^2/day, IV, Days 1-5 of each cycle;

Drug: fluorouracil
Given IV as described in Arm Description
Other Names:
  • 5-fluorouracil
  • 5-FU
  • NSC-19893

    • Drug: leucovorin calcium
    Given IV as described in Arm description.
    Other Names:
  • Leucovorin
  • Folinic acid
  • NSC-3590

    • Drug: levamisole hydrochloride
    Given as described in arm description
    Other Names:
  • Levamisole
  • NSC-177023

    		•
    Active Comparator: Infusional 5-FU + Levamisole

    levamisole hydrochloride : 50 mg every 8 hours x 3 days, PO, repeat every 14 days for 6 months; 5-fluorouracil: 250 mg/m^2/day, continuous infusion, daily for 56 days x 3 cycles of 8 weeks.

    Drug: fluorouracil
    Given IV as described in Arm Description
    Other Names:
  • 5-fluorouracil
  • 5-FU
  • NSC-19893

    • Drug: levamisole hydrochloride
    Given as described in arm description
    Other Names:
  • Levamisole
  • NSC-177023

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [At death]

    Secondary Outcome Measures

    1. Disease free survival [Until progression]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    1. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CCOP - Scottsdale Oncology Program Scottsdale Arizona United States 85259-5404
    2 Veterans Affairs Medical Center - Palo Alto Palo Alto California United States 94304
    3 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94115-0128
    4 Stanford University Medical Center Stanford California United States 94305-5408
    5 CCOP - Colorado Cancer Research Program, Inc. Denver Colorado United States 80209-5031
    6 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    7 Sylvester Cancer Center, University of Miami Miami Florida United States 33136
    8 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    9 Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia United States 30033
    10 Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois United States 60611
    11 Veterans Affairs Medical Center - Chicago (Lakeside) Chicago Illinois United States 60611
    12 University of Chicago Cancer Research Center Chicago Illinois United States 60637
    13 CCOP - Illinois Oncology Research Association Peoria Illinois United States 61602
    14 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    15 CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa United States 52403-1206
    16 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 10309-1016
    17 Siouxland Hematology-Oncology Sioux City Iowa United States 51101-1733
    18 CCOP - Ochsner New Orleans Louisiana United States 70121
    19 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    20 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    21 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    22 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    23 CCOP - Duluth Duluth Minnesota United States 55805
    24 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    25 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    26 CentraCare Clinic Saint Cloud Minnesota United States 56303
    27 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    28 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
    29 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68131
    30 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    31 Veterans Affairs Medical Center - Albany Albany New York United States 12208
    32 Albert Einstein Comprehensive Cancer Center Bronx New York United States 10461
    33 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    34 North Shore University Hospital Manhasset New York United States 11030
    35 Mount Sinai Medical Center, NY New York New York United States 10029
    36 University of Rochester Cancer Center Rochester New York United States 14642
    37 State University of New York - Upstate Medical University Syracuse New York United States 13210
    38 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    39 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    40 Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157-1082
    41 Quain & Ramstad Clinic, P.C. Bismarck North Dakota United States 58501
    42 Altru Health Systems Grand Forks North Dakota United States 58201
    43 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    44 CCOP - Toledo Community Hospital Oncology Program Toledo Ohio United States 43623-3456
    45 CCOP - Geisinger Clinical and Medical Center Danville Pennsylvania United States 17822-2001
    46 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    47 University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15213
    48 Rhode Island Hospital Providence Rhode Island United States 02903
    49 Rapid City Regional Hospital Rapid City South Dakota United States 57709
    50 CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota United States 57105-1080
    51 University of Tennessee, Memphis Cancer Center Memphis Tennessee United States 38163
    52 Vermont Cancer Center Burlington Vermont United States 05401-3498
    53 Veterans Affairs Medical Center - Madison Madison Wisconsin United States 53705
    54 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792
    55 CCOP - Marshfield Medical Research and Education Foundation Marshfield Wisconsin United States 54449
    56 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    57 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295
    58 Saskatchewan Cancer Agency Regina Saskatchewan Canada S4S 6X3
    59 Veterans Affairs Medical Center - San Juan San Juan Puerto Rico 00927-5800
    60 Pretoria Academic Hospital Pretoria South Africa 0001

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)
    • Cancer and Leukemia Group B
    • Eastern Cooperative Oncology Group
    • North Central Cancer Treatment Group

    Investigators

    • Study Chair: Elizabeth A. Poplin, MD, Rutgers Cancer Institute of New Jersey
    • Study Chair: Robert J. Mayer, MD, FACP, Dana-Farber Cancer Institute
    • Study Chair: Daniel G. Haller, MD, Abramson Cancer Center of the University of Pennsylvania
    • Study Chair: Richard M. Goldberg, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00002593
    Other Study ID Numbers:
    • CDR0000063773
    • SWOG-9415
    • CLB-9498
    • INT-0153
    • U10CA032102
    First Posted:
    Aug 31, 2004
    Last Update Posted:
    Jan 3, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Southwest Oncology Group
    stage II colon cancer
    stage III colon cancer
    Additional relevant MeSH terms:
    Colonic Neoplasms
    Leucovorin
    Levamisole
    Fluorouracil
    Calcium
    Levoleucovorin

    Study Results

    No Results Posted as of Jan 3, 2013