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

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: fluorouracil; Drug: leucovorin calcium; Drug: levamisole hydrochloride

• 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.

Study Timeline

• Study Start: 1994-12
• Study First Submitted: 1999-11-01
• Primary Completion: 1999-12
• Study First Submitted QC: 2004-08-30
• Study First Posted: 2004-08-31
• Study Completion: 2005-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-03

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

Group	Intervention	Description
5-FU/Leucovorin/Levamisole	leucovorin calcium	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;
5-FU/Leucovorin/Levamisole	levamisole hydrochloride	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;
Infusional 5-FU + Levamisole	levamisole hydrochloride	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.
5-FU/Leucovorin/Levamisole	fluorouracil	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;
Infusional 5-FU + Levamisole	fluorouracil	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Disease free survival	Until 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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