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Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer

A Randomized, Double-blind, Placebo-controlled, Phase III Study of Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo in Patients With Previously Treated Metastatic Adenocarcinoma of the Colon or Rectum

NCT00056446•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and whose disease has worsened after treatment with irinotecan.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmed adenocarcinoma of the colon or rectum in patients with metastatic disease
•One prior chemotherapy regimen with irinotecan and 5FU
•Evidence of progressive disease within 6 months after last dose of irinotecan
•WHO Performance Status of 0, 1, or 2
•Measurable tumors
•Adequate hematologic status, liver and kidney function
•Life expectancy greater than 12 weeks
•Written informed consent obtained

Exclusion Criteria

•History or presence of central nervous system disease
•Patients with a history of another primary cancer within 5 years
•Prior chemotherapy within 3 weeks before entry to study
•Major surgery within 4 weeks or minor surgery within 2 weeks before entry to study
•Investigational drugs within 4 weeks before entry to study
•Prior therapy with oxaliplatin
•Peripheral neuropathy with functional impairment
•Female patients who are pregnant or breast feeding
•Any severe or uncontrolled medical condition which could prevent participation in study
•Chronic kidney disease
+2 more criteria

Locations (251)

Comprehensive Cancer Institute

Huntsville, Alabama, United States

Alaska Oncology and Hematology

Anchorage, Alaska, United States

Arizona Clinical Research Center

Tucson, Arizona, United States

Northeast Arkansas Clinic

Jonesboro, Arkansas, United States

Arkansas Cancer Research Center

Little Rock, Arkansas, United States

Little Rock Hematology & Oncology

Little Rock, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Providence St. Joseph Medical Center

Burbank, California, United States

Compassionate Cancer Care Medical Group, Inc.

Fountain Valley, California, United States

Key Dates

Start Date

January 1, 2003

Primary Completion Date

January 1, 2007

Completion Date

January 1, 2007

Last Updated

March 6, 2017

Enrollment

855

ACTUAL participants

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Vatalanib

DRUG

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

NCT06662786

Colorectal Neoplasms

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RECRUITINGPHASE1

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

NCT06663319

Colorectal NeoplasmsGastrointestinal Neoplasms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)

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Comprehensive Analysis of Gut Microbiota Signatures in Metastatic Colorectal Cancer

DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition