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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Novartis
Bayer
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00056459
  Purpose

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 are seeking first chemotherapy treatment


Condition Intervention Phase
Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Drug: Vatalanib
Phase III

MedlinePlus related topics:   Cancer    Colorectal Cancer   

ChemIDplus related topics:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Vatalanib    Butanedioic acid, compd. with N-(4-chlorophenyl)-4-(4-pyridinylmethyl)-1-phthalazinamine (1:1)    Fluorouracil    Oxaliplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression free survival

Secondary Outcome Measures:
  • Overall survival
  • Time to progression
  • Time to treatment failure
  • Best overall response rate
  • Tolerability and safety profile

Estimated Enrollment:   1090
Study Start Date:   February 2003
Estimated Study Completion Date:   May 2004

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion criteria

  • Patients with metastatic colorectal cancer coming for initial chemotherapy
  • Documented metastatic colorectal cancer
  • 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 for metastatic colorectal cancer
  • Prior full field radiotherapy within 4 weeks or limited field radiotherapy within 2 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 anti-VEGF agents
  • Any prior therapy with oxaliplatin or allergy to platinum-containing drugs
  • Peripheral neuropathy with functional impairment
  • Female patients who are pregnant or breast feeding
  • Any severe or uncontrolled medical conditions which could prevent participation in study
  • Patients who are taking Coumadin

Other protocol-defined inclusion / exclusion criteria may apply

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056459

Show 223 study locations  Show 223 Study Locations

Sponsors and Collaborators
Novartis
Bayer

Investigators
Study Chair:     Novartis / Schering AG, Germany     Novartis / Schering AG, Germany    
  More Information

Study ID Numbers:   CPTK787 0135/306241, CONFIRM 1
First Received:   March 13, 2003
Last Updated:   September 6, 2007
ClinicalTrials.gov Identifier:   NCT00056459
Health Authority:   United States: Food and Drug Administration

Keywords provided by Novartis:
Colorectal Cancer  
PTK787  
Vatalanib  
VEGF inhibitor  
Oxaliplatin  
Angiogenesis
Rectal Cancer
Colon Cancer
Colorectal Carcinoma
Colorectal Tumor

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Vatalanib
Rectal neoplasm
Carcinoma
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colonic Neoplasms
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on August 28, 2008




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