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

NCT ID: NCT00002593

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-12-31
• Study Completion Date: 2005-03-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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;

Group Type: ACTIVE_COMPARATOR

fluorouracil

Intervention Type: DRUG

Given IV as described in Arm Description

leucovorin calcium

Intervention Type: DRUG

Given IV as described in Arm description.

levamisole hydrochloride

Intervention Type: DRUG

Given as described in arm description

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.

Group Type: ACTIVE_COMPARATOR

fluorouracil

Intervention Type: DRUG

Given IV as described in Arm Description

levamisole hydrochloride

Intervention Type: DRUG

Given as described in arm description

Interventions

fluorouracil

Given IV as described in Arm Description

Intervention Type: DRUG

leucovorin calcium

Given IV as described in Arm description.

Intervention Type: DRUG

levamisole hydrochloride

Given as described in arm description

Intervention Type: DRUG

Other Intervention Names

5-fluorouracil; 5-FU; NSC-19893; Leucovorin; Folinic acid; NSC-3590; Levamisole; NSC-177023

Eligibility Criteria

Inclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Cancer and Leukemia Group B

NETWORK

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: collaborator

North Central Cancer Treatment Group

NETWORK

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth A. Poplin, MD

Role: STUDY_CHAIR

Rutgers Cancer Institute of New Jersey

Robert J. Mayer, MD, FACP

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Daniel G. Haller, MD

Role: STUDY_CHAIR

Abramson Cancer Center at Penn Medicine

Richard M. Goldberg, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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 D.C., 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

Veterans Affairs Medical Center - Chicago (Lakeside)

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Siouxland Hematology-Oncology

Sioux City, Iowa, United States

CCOP - Ochsner

New Orleans, Louisiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

CCOP - Duluth

Duluth, Minnesota, United States

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

CentraCare Clinic

Saint Cloud, Minnesota, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Veterans Affairs Medical Center - Albany

Albany, New York, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Mount Sinai Medical Center, NY

New York, New York, United States

University of Rochester Cancer Center

Rochester, New York, United States

State University of New York - Upstate Medical University

Syracuse, New York, United States

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Quain & Ramstad Clinic, P.C.

Bismarck, North Dakota, United States

Altru Health Systems

Grand Forks, North Dakota, United States

Ireland Cancer Center

Cleveland, Ohio, United States

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, United States

CCOP - Geisinger Clinical and Medical Center

Danville, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, United States

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, United States

Vermont Cancer Center

Burlington, Vermont, United States

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, United States

Saskatchewan Cancer Agency

Regina, Saskatchewan, Canada

Veterans Affairs Medical Center - San Juan

San Juan, , Puerto Rico

Pretoria Academic Hospital

Pretoria, , South Africa

Countries

United States; Canada; Puerto Rico; South Africa

References

Yothers G, Sargent DJ, Wolmark N, Goldberg RM, O'Connell MJ, Benedetti JK, Saltz LB, Dignam JJ, Blackstock AW; ACCENT Collaborative Group. Outcomes among black patients with stage II and III colon cancer receiving chemotherapy: an analysis of ACCENT adjuvant trials. J Natl Cancer Inst. 2011 Oct 19;103(20):1498-506. doi: 10.1093/jnci/djr310. Epub 2011 Oct 12.

Reference Type: BACKGROUND

PMID: 21997132 (View on PubMed)

Poplin EA, Benedetti JK, Estes NC, Haller DG, Mayer RJ, Goldberg RM, Weiss GR, Rivkin SE, Macdonald JS. Phase III Southwest Oncology Group 9415/Intergroup 0153 randomized trial of fluorouracil, leucovorin, and levamisole versus fluorouracil continuous infusion and levamisole for adjuvant treatment of stage III and high-risk stage II colon cancer. J Clin Oncol. 2005 Mar 20;23(9):1819-25. doi: 10.1200/JCO.2005.04.169.

Reference Type: RESULT

PMID: 15774775 (View on PubMed)

Poplin E, Benedetti J, Estes N, et al.: Phase III randomized trial of bolus 5-FU/leucovorin/levamisole versus 5-FU continuous infusion/levamisole as adjuvant therapy for high risk colon cancer (SWOG 9415/INT-0153). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A931, 2000.

Reference Type: RESULT

Leichman CG, Poplin E, Zalupski M, et al.: A pilot trial of infusion 5-fluorouracil with levamisole as adjuvant therapy for stage III colon cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-460, 196, 1995.

Reference Type: RESULT

Other Identifiers

SWOG-9415

Identifier Type: OTHER

Identifier Source: secondary_id

CLB-9498

Identifier Type: OTHER

Identifier Source: secondary_id

INT-0153

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000063773

Identifier Type: -

Identifier Source: org_study_id