Leucovorin and Fluorouracil With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
NCT ID: NCT00004252
Last Updated: 2012-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1999-11-30
2007-09-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of leucovorin and fluorouracil with or without SU5416 in treating patients who have metastatic colorectal cancer.
Detailed Description
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OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified according to performance status (ECOG 0 vs 1), site of primary disease (colon vs rectum), measurable or evaluable disease, and prior fluorouracil adjuvant chemotherapy (none vs at least 1 dose). Patients are randomized to one of two treatment arms: Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV bolus 1 hour into leucovorin calcium administration weekly for 6 weeks. Arm II: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV bolus 1 hour into leucovorin calcium administration weekly for 6 weeks, plus SU5416 twice weekly for 8 weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to study, at weeks 4 and 8 of each course, and then post study. Patients are followed post study at one month and then every 2 months until death.
PROJECTED ACCRUAL: A total of 710 patients (355 per treatment arm) will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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fluorouracil
leucovorin calcium
semaxanib
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 2.2 mg/dL AST no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 50 mL/min Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No known allergy to Cremophor or Cremophor based drug products No uncontrolled colon or small bowel disorders No other malignancy within the past 5 years, except: Basal cell skin cancer Carcinoma in situ of the cervix No other acute or chronic medical or psychiatric condition, or laboratory abnormality that would preclude compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy, vaccine therapy, cytokine therapy, or biologic therapy for metastatic disease No prior angiogenesis inhibition therapy (e.g., metalloproteinase inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody therapy or other experimental drugs acting directly on the VEGF/Flk-1 signaling pathway) Prior antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or radioimmunotherapy allowed in adjuvant setting only Concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) allowed for anemia, neutropenia, or thrombocytopenia No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy for metastatic disease No prior intra-arterial cytotoxic chemotherapy No more than one prior course of fluorouracil based adjuvant therapy (e.g., intravenous fluorouracil or capecitabine) with the last dose administered at least 6 months ago No prior SU5416 No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy Concurrent localized palliative radiotherapy allowed unless indicative of disease progression Surgery: At least 4 weeks since prior major surgery (not including surgical placement of a venous access device) Prior surgical resection of hepatic metastases allowed Other: No prior investigational therapy for metastatic disease No other concurrent investigational agents
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Alison L. Hannah, MBBS
Role: STUDY_CHAIR
SUGEN
Locations
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Alabama Oncology, LLC
Montgomery, Alabama, United States
Office of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee
Arcadia, California, United States
Scripps Clinic
La Jolla, California, United States
Tower Hematology Oncology Medical Group
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
St. Francis Hospital
San Francisco, California, United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Cancer Center of Boston
Boston, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
APN-IMPATH Research Corporation
Fort Lee, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New York Medical College
Valhalla, New York, United States
Presbyterian Healthcare
Charlotte, North Carolina, United States
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, United States
Hematology/Oncology Associates of NE Pennsylvania, P.C.
Scranton, Pennsylvania, United States
Associates in Oncology & Hematology
Chattanooga, Tennessee, United States
Dial Research Associates, Inc.
Nashville, Tennessee, United States
Presbyterian Hospital of Dallas
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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CDR0000067499
Identifier Type: -
Identifier Source: secondary_id
UCLA-9909008
Identifier Type: -
Identifier Source: secondary_id
SUGEN-SU5416.031
Identifier Type: -
Identifier Source: org_study_id