Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer

NCT ID: NCT00016198

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2010-12-31

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 may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.

Detailed Description

OBJECTIVES: I. Compare the overall response rate and overall survival of patients with recurrent metastatic colorectal adenocarcinoma treated with third-line therapy comprising fluorouracil and leucovorin calcium with or without oxaliplatin. II. Compare the onset and duration of complete and partial responses and duration of disease stabilization in patients treated with these regimens. III. Compare the proportion of patients with stable disease and proportion of patients with tumor-related symptomatic improvement treated with these regimens. IV. Compare the time to disease progression and time to tumor-related symptomatic worsening in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on day 1. On day 2, patients receive leucovorin calcium and fluorouracil as in arm I. Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease progression. Patients are followed at day 30 and then for approximately 6 months.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.

Conditions

Colorectal Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

FOLFOX regimen

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the colon or rectum Metastatic/recurrent disease not amenable to potentially curative therapy (e.g., inoperable metastatic disease) Documented sequential disease progression (by CT scan or MRI) after 2 prior chemotherapy regimens for metastatic/recurrent disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional CT scan or MRI OR At least 10 mm by spiral CT scan Must have received prior fluorouracil (or capecitabine) and leucovorin calcium with or without irinotecan as first-line therapy and irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium as second-line therapy for metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (6 times ULN if documented liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if documented liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia No unstable angina No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia No extensive and symptomatic fibrosis of the lung Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No known peripheral neuropathy (absence of deep tendon reflexes as the sole neurologic abnormality allowed) No diabetes or active infection No known dihydropyrimidine dehydrogenase deficiency

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior anticancer biologic therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No prior adjuvant irinotecan Prior adjuvant fluorouracil and leucovorin calcium allowed At least 3 weeks since prior chemotherapy (e.g., second-line irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium) for metastatic disease and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to target lesion unless documented progression within the radiation portal Surgery: See Disease Characteristics At least 4 weeks since prior surgery for primary tumor or metastases and recovered Other: No prior investigational anticancer drug No other concurrent investigational agents

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

Sponsors

Prologue Research International

INDUSTRY

Sponsor Role: lead

Principal Investigators

Richard A. Gams, MD

Role: STUDY_CHAIR

Prologue Research International

Locations

Arizona Clinical Research Center

Tucson, Arizona, United States

Arkansas Cancer Clinic, P.A.

Pine Bluff, Arkansas, United States

Citrus Valley Medical Center

Covina, California, United States

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, United States

California Cancer Care, Inc.

Greenbrae, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Kenmar Research Institute

Los Angeles, California, United States

Comprehensive Cancer Centers of the Desert

Palm Springs, California, United States

Kaiser Permanente-Southern California Permanente Medical Group

San Diego, California, United States

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

John Muir Medical Center

Walnut Creek, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Northwestern Connecticut Oncology-Hematology Associates

Torrington, Connecticut, United States

Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Center for Hematology-Oncology

Boca Raton, Florida, United States

Halifax Medical Center

Daytona Beach, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Hematology/Oncology Associates

Jacksonville, Florida, United States

Lake Heart and Cancer Medical Center

Leesburg, Florida, United States

Oncology-Hematology Group of South Florida

Miami, Florida, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Hematology/Oncology Associates

Port Saint Lucie, Florida, United States

Northwest Medical Specialists, P.C.

Arlington Heights, Illinois, United States

Dreyer Medical Clinic

Aurora, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, United States

Hope Center

Terre Haute, Indiana, United States

Medical Oncology and Hematology Associates

Des Moines, Iowa, United States

Mercy Cancer Center

Mason City, Iowa, United States

Lucille Parker Markey Cancer Center, University of Kentucky

Lexington, Kentucky, United States

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Baton Rouge General Medical Center

Baton Rouge, Louisiana, United States

Cancer and Blood Institute

Metairie, Louisiana, United States

Saints Memorial Medical Center

Lowell, Massachusetts, United States

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Medical Oncology Group

Gulfport, Mississippi, United States

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, United States

Deaconess Billings Clinic

Billings, Montana, United States

Monmouth Medical Center

Long Branch, New Jersey, United States

Jersey Shore Cancer Center

Neptune City, New Jersey, United States

Central Jersey Oncology Center

New Brunswick, New Jersey, United States

Hematology Associates of New Jersey, P.A.

Ridgewood, New Jersey, United States

Monmouth Hematology-Oncology Associates, P.A.

West Long Branch, New Jersey, United States

University of New Mexico Cancer Research & Treatment Center

Albuquerque, New Mexico, United States

HemOnCare, P.C.

Brooklyn, New York, United States

North Shore Hematology/Oncology Associates, P.C.

East Setauket, New York, United States

Reddy Cancer Treatment Center

Malone, New York, United States

New York University Medical Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Interlakes Oncology/Hematology PC

Rochester, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

South Shore Hematology Oncology Associates, P.C.

Rockville Centre, New York, United States

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

New York Medical College

Valhalla, New York, United States

Mid-Ohio Oncology/Hematology, Inc.

Columbus, Ohio, United States

Hematology Oncology Consultants Inc

Columbus, Ohio, United States

Lawrence M. Stallings Medical Practice

Wooster, Ohio, United States

Oklahoma Oncology Inc.

Tulsa, Oklahoma, United States

Bend Memorial Clinic

Bend, Oregon, United States

Salem Hospital Regional Cancer Center

Salem, Oregon, United States

Oncology Hematology of Lehigh Valley, P.C.

Bethlehem, Pennsylvania, United States

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, United States

Lifespan: The Miriam Hospital

Providence, Rhode Island, United States

Memorial Hospital Cancer Center - Chattanooga

Chattanooga, Tennessee, United States

Family Cancer Center

Collierville, Tennessee, United States

Baptist Regional Cancer Center

Knoxville, Tennessee, United States

West Cancer Clinic

Memphis, Tennessee, United States

Center for Oncology Research and Treatment, Medical City Hospital

Dallas, Texas, United States

Cancer Therapy and Research Center

San Antonio, Texas, United States

Scott and White Memorial Hospital

Temple, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Intermountain Hematology/Oncology Associates, Inc.

Salt Lake City, Utah, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Countries

United States

Other Identifiers

CDR0000068606

Identifier Type: REGISTRY

Identifier Source: secondary_id

SANOFI-EFC4760

Identifier Type: -

Identifier Source: secondary_id

PROLOGUE-EFC4760

Identifier Type: -

Identifier Source: org_study_id