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

Colorectal Cancer Clinical Trial

Official title:

A Randomized, Multicenter, Phase II Study Of Bolus/Infusion 5-FU/LV (de Gramont Regimen) Versus Oxaliplatin And Bolus/Infusion 5-FU/LV (de Gramont Regimen) As Third-Line Treatment Of Patients With Metastatic Colorectal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016198
• Other study ID #: PROLOGUE-EFC4760
• Secondary ID: CDR0000068606SAN
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2001
• Last updated: June 25, 2013
• Start date: May 2001
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• FOLFOX regimen

• fluorouracil

• leucovorin calcium

• oxaliplatin

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Research & Treatment Center	Albuquerque	New Mexico
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Northwest Medical Specialists, P.C.	Arlington Heights	Illinois
United States	Dreyer Medical Clinic	Aurora	Illinois
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana
United States	Bend Memorial Clinic	Bend	Oregon
United States	Oncology Hematology of Lehigh Valley, P.C.	Bethlehem	Pennsylvania
United States	Deaconess Billings Clinic	Billings	Montana
United States	Center for Hematology-Oncology	Boca Raton	Florida
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	HemOnCare, P.C.	Brooklyn	New York
United States	Memorial Hospital Cancer Center - Chattanooga	Chattanooga	Tennessee
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	Family Cancer Center	Collierville	Tennessee
United States	Hematology Oncology Consultants Inc	Columbus	Ohio
United States	Mid-Ohio Oncology/Hematology, Inc.	Columbus	Ohio
United States	Citrus Valley Medical Center	Covina	California
United States	Center for Oncology Research and Treatment, Medical City Hospital	Dallas	Texas
United States	Halifax Medical Center	Daytona Beach	Florida
United States	Cancer Care Specialists of Central Illinois, S.C.	Decatur	Illinois
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Medical Oncology and Hematology Associates	Des Moines	Iowa
United States	Cancer Center and Beckman Research Institute, City of Hope	Duarte	California
United States	North Shore Hematology/Oncology Associates, P.C.	East Setauket	New York
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	California Cancer Care, Inc.	Greenbrae	California
United States	Medical Oncology Group	Gulfport	Mississippi
United States	Jackson Oncology Associates, PLLC	Jackson	Mississippi
United States	Hematology/Oncology Associates	Jacksonville	Florida
United States	Baptist Regional Cancer Center	Knoxville	Tennessee
United States	Lake Heart and Cancer Medical Center	Leesburg	Florida
United States	Lucille Parker Markey Cancer Center, University of Kentucky	Lexington	Kentucky
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Kenmar Research Institute	Los Angeles	California
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Saints Memorial Medical Center	Lowell	Massachusetts
United States	Reddy Cancer Treatment Center	Malone	New York
United States	Mercy Cancer Center	Mason City	Iowa
United States	West Cancer Clinic	Memphis	Tennessee
United States	Cancer and Blood Institute	Metairie	Louisiana
United States	Oncology-Hematology Group of South Florida	Miami	Florida
United States	Jersey Shore Cancer Center	Neptune	New Jersey
United States	Central Jersey Oncology Center	New Brunswick	New Jersey
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	New York University Medical Center	New York	New York
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	Comprehensive Cancer Centers of the Desert	Palm Springs	California
United States	Pennsylvania Oncology Hematology Associates	Philadelphia	Pennsylvania
United States	Arkansas Cancer Clinic, P.A.	Pine Bluff	Arkansas
United States	Hematology/Oncology Associates	Port Saint Lucie	Florida
United States	Lifespan: The Miriam Hospital	Providence	Rhode Island
United States	Hematology Associates of New Jersey, P.A.	Ridgewood	New Jersey
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	St. Joseph Oncology, Inc.	Saint Joseph	Missouri
United States	Salem Hospital Regional Cancer Center	Salem	Oregon
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Intermountain Hematology/Oncology Associates, Inc.	Salt Lake City	Utah
United States	Cancer Therapy and Research Center	San Antonio	Texas
United States	Kaiser Permanente-Southern California Permanente Medical Group	San Diego	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Scott and White Memorial Hospital	Temple	Texas
United States	Hope Center	Terre Haute	Indiana
United States	Northwestern Connecticut Oncology-Hematology Associates	Torrington	Connecticut
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	Oklahoma Oncology Inc.	Tulsa	Oklahoma
United States	New York Medical College	Valhalla	New York
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	John Muir Medical Center	Walnut Creek	California
United States	Lombardi Cancer Center	Washington	District of Columbia
United States	Monmouth Hematology-Oncology Associates, P.A.	West Long Branch	New Jersey
United States	Lawrence M. Stallings Medical Practice	Wooster	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Prologue Research International

Country where clinical trial is conducted

United States,