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

Phase 3
Completed
Conditions
Colorectal Cancer
Interventions
Registration Number
NCT00002593
Lead Sponsor
SWOG Cancer Research Network
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1135
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
5-FU/Leucovorin/Levamisoleleucovorin calciumlevamisole 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;
5-FU/Leucovorin/Levamisolelevamisole hydrochloridelevamisole 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;
Infusional 5-FU + Levamisolelevamisole hydrochloridelevamisole 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.
5-FU/Leucovorin/Levamisolefluorouracillevamisole 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;
Infusional 5-FU + Levamisolefluorouracillevamisole 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.
Primary Outcome Measures
NameTimeMethod
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 survivalAt death
Secondary Outcome Measures
NameTimeMethod
Disease free survivalUntil progression

Trial Locations

Locations (60)

CCOP - Scottsdale Oncology Program

🇺🇸

Scottsdale, Arizona, United States

Veterans Affairs Medical Center - Palo Alto

🇺🇸

Palo Alto, California, United States

UCSF Cancer Center and Cancer Research Institute

🇺🇸

San Francisco, California, United States

Stanford University Medical Center

🇺🇸

Stanford, California, United States

CCOP - Colorado Cancer Research Program, Inc.

🇺🇸

Denver, Colorado, United States

Walter Reed Army Medical Center

🇺🇸

Washington, District of Columbia, United States

Sylvester Cancer Center, University of Miami

🇺🇸

Miami, Florida, United States

Emory University Hospital - Atlanta

🇺🇸

Atlanta, Georgia, United States

Veterans Affairs Medical Center - Atlanta (Decatur)

🇺🇸

Decatur, Georgia, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

🇺🇸

Chicago, Illinois, United States

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CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States

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