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

NCT00016198 | Completed Phase 2

• 3 other identifiers: PROLOGUE-EFC4760CDR0000068606SANOFI-EFC4760
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 74

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.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Interventions

FOLFOX regimen DRUG

fluorouracil DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Prologue Research International: lead

Study Sites (74)

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Arkansas Cancer Clinic, P.A.

Pine Bluff, Arkansas, 71603, United States

Location

Citrus Valley Medical Center

Covina, California, 92807, United States

Location

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

California Cancer Care, Inc.

Greenbrae, California, 94904, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Kenmar Research Institute

Los Angeles, California, 90057, United States

Location

Comprehensive Cancer Centers of the Desert

Palm Springs, California, 92262, United States

Location

Kaiser Permanente-Southern California Permanente Medical Group

San Diego, California, 92120, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

John Muir Medical Center

Walnut Creek, California, 94598, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Northwestern Connecticut Oncology-Hematology Associates

Torrington, Connecticut, 06790, United States

Location

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Center for Hematology-Oncology

Boca Raton, Florida, 33486, United States

Location

Halifax Medical Center

Daytona Beach, Florida, 32114, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Hematology/Oncology Associates

Jacksonville, Florida, 32216, United States

Location

Lake Heart and Cancer Medical Center

Leesburg, Florida, 34748, United States

Location

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Hematology/Oncology Associates

Port Saint Lucie, Florida, 34952, United States

Location

Northwest Medical Specialists, P.C.

Arlington Heights, Illinois, 60004, United States

Location

Dreyer Medical Clinic

Aurora, Illinois, 60506, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Cancer Care Specialists of Central Illinois, S.C.

Decatur, Illinois, 62526, United States

Location

Hope Center

Terre Haute, Indiana, 47809, United States

Location

Medical Oncology and Hematology Associates

Des Moines, Iowa, 50309, United States

Location

Mercy Cancer Center

Mason City, Iowa, 50401, United States

Location

Lucille Parker Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70821-2511, United States

Location

Cancer and Blood Institute

Metairie, Louisiana, 70006, United States

Location

Saints Memorial Medical Center

Lowell, Massachusetts, 01852, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Medical Oncology Group

Gulfport, Mississippi, 39501, United States

Location

Jackson Oncology Associates, PLLC

Jackson, Mississippi, 39202, United States

Location

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, 64506, United States

Location

Deaconess Billings Clinic

Billings, Montana, 59107-5100, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Jersey Shore Cancer Center

Neptune City, New Jersey, 07753, United States

Location

Central Jersey Oncology Center

New Brunswick, New Jersey, 08901, United States

Location

Hematology Associates of New Jersey, P.A.

Ridgewood, New Jersey, 07450, United States

Location

Monmouth Hematology-Oncology Associates, P.A.

West Long Branch, New Jersey, 07764, United States

Location

University of New Mexico Cancer Research & Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

HemOnCare, P.C.

Brooklyn, New York, 11235, United States

Location

North Shore Hematology/Oncology Associates, P.C.

East Setauket, New York, 11733, United States

Location

Reddy Cancer Treatment Center

Malone, New York, 12953, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

South Shore Hematology Oncology Associates, P.C.

Rockville Centre, New York, 11570, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Mid-Ohio Oncology/Hematology, Inc.

Columbus, Ohio, 43213, United States

Location

Hematology Oncology Consultants Inc

Columbus, Ohio, 43235, United States

Location

Lawrence M. Stallings Medical Practice

Wooster, Ohio, 44691, United States

Location

Oklahoma Oncology Inc.

Tulsa, Oklahoma, 74104, United States

Location

Bend Memorial Clinic

Bend, Oregon, 97701, United States

Location

Salem Hospital Regional Cancer Center

Salem, Oregon, 97309-5014, United States

Location

Oncology Hematology of Lehigh Valley, P.C.

Bethlehem, Pennsylvania, 18015, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19107, United States

Location

Lifespan: The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Memorial Hospital Cancer Center - Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Family Cancer Center

Collierville, Tennessee, 38017, United States

Location

Baptist Regional Cancer Center

Knoxville, Tennessee, 37920, United States

Location

West Cancer Clinic

Memphis, Tennessee, 38120, United States

Location

Center for Oncology Research and Treatment, Medical City Hospital

Dallas, Texas, 75230, United States

Location

Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Intermountain Hematology/Oncology Associates, Inc.

Salt Lake City, Utah, 84124, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Folfox protocol; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Richard A. Gams, MD

  Prologue Research International

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 7, 2004
• Study Start: May 1, 2001
• Primary Completion: April 1, 2003
• Study Completion: December 1, 2010
• Last Updated: June 26, 2013

Record last verified: 2010-12

Locations

US (74)