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

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

Sponsors

Lead Sponsor: Southwest Oncology Group

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

Source Southwest Oncology Group
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.

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.

Overall Status Completed
Start Date 1994-12-01
Completion Date 2005-03-01
Primary Completion Date 1999-12-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
Disease free survival Until progression
Enrollment 1135
Condition
Intervention

Intervention Type: Drug

Intervention Name: fluorouracil

Description: Given IV as described in Arm Description

Intervention Type: Drug

Intervention Name: leucovorin calcium

Description: Given IV as described in Arm description.

Arm Group Label: 5-FU/Leucovorin/Levamisole

Intervention Type: Drug

Intervention Name: levamisole hydrochloride

Description: Given as described in arm description

Eligibility

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Location
Facility:
CCOP - Scottsdale Oncology Program | Scottsdale, Arizona, 85259-5404, United States
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California, 94304, United States
UCSF Cancer Center and Cancer Research Institute | San Francisco, California, 94115-0128, United States
Stanford University Medical Center | Stanford, California, 94305-5408, United States
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado, 80209-5031, United States
Walter Reed Army Medical Center | Washington, District of Columbia, 20307-5000, United States
Sylvester Cancer Center, University of Miami | Miami, Florida, 33136, United States
Emory University Hospital - Atlanta | Atlanta, Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia, 30033, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois, 60611, United States
Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois, 60611, United States
University of Chicago Cancer Research Center | Chicago, Illinois, 60637, United States
CCOP - Illinois Oncology Research Association | Peoria, Illinois, 61602, United States
CCOP - Carle Cancer Center | Urbana, Illinois, 61801, United States
CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa, 52403-1206, United States
CCOP - Iowa Oncology Research Association | Des Moines, Iowa, 10309-1016, United States
Siouxland Hematology-Oncology | Sioux City, Iowa, 51101-1733, United States
CCOP - Ochsner | New Orleans, Louisiana, 70121, United States
Dana-Farber Cancer Institute | Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center | Boston, Massachusetts, 02215, United States
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts, 01655, United States
CCOP - Kalamazoo | Kalamazoo, Michigan, 49007-3731, United States
CCOP - Duluth | Duluth, Minnesota, 55805, United States
University of Minnesota Cancer Center | Minneapolis, Minnesota, 55455, United States
Mayo Clinic Cancer Center | Rochester, Minnesota, 55905, United States
CentraCare Clinic | Saint Cloud, Minnesota, 56303, United States
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota, 55416, United States
Barnes-Jewish Hospital | Saint Louis, Missouri, 63110, United States
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska, 68131, United States
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada, 89106, United States
Veterans Affairs Medical Center - Albany | Albany, New York, 12208, United States
Albert Einstein Comprehensive Cancer Center | Bronx, New York, 10461, United States
Roswell Park Cancer Institute | Buffalo, New York, 14263-0001, United States
North Shore University Hospital | Manhasset, New York, 11030, United States
Mount Sinai Medical Center, NY | New York, New York, 10029, United States
University of Rochester Cancer Center | Rochester, New York, 14642, United States
State University of New York - Upstate Medical University | Syracuse, New York, 13210, United States
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina, 27599-7295, United States
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina, 27157-1082, United States
Quain & Ramstad Clinic, P.C. | Bismarck, North Dakota, 58501, United States
Altru Health Systems | Grand Forks, North Dakota, 58201, United States
Ireland Cancer Center | Cleveland, Ohio, 44106-5065, United States
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio, 43623-3456, United States
CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania, 17822-2001, United States
Fox Chase Cancer Center | Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital | Providence, Rhode Island, 02903, United States
Rapid City Regional Hospital | Rapid City, South Dakota, 57709, United States
CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota, 57105-1080, United States
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee, 38163, United States
Vermont Cancer Center | Burlington, Vermont, 05401-3498, United States
Veterans Affairs Medical Center - Madison | Madison, Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin, 53792, United States
CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin, 53295, United States
Saskatchewan Cancer Agency | Regina, Saskatchewan, S4S 6X3, Canada
Veterans Affairs Medical Center - San Juan | San Juan, 00927-5800, Puerto Rico
Pretoria Academic Hospital | Pretoria, 0001, South Africa
Location Countries

Canada

Puerto Rico

South Africa

United States

Verification Date

2013-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 5-FU/Leucovorin/Levamisole

Type: Active Comparator

Description: 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;

Label: Infusional 5-FU + Levamisole

Type: Active Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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