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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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00056446
First received: March 13, 2003
Last updated: November 18, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms
 Drug: Vatalanib
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall survival [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
  • Tumor response rate [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
  • Tolerability and safety profile [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]

Enrollment: 855
Study Start Date: January 2003
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oxaliplatin/5-FU/LV and PTK787/ZK 222584
 Drug: Vatalanib
Other Name: PTK787/ZK 222584
Placebo Comparator: 2
Oxaliplatin/5-FU/LV and placebo
 Drug: Vatalanib
Other Name: PTK787/ZK 222584

  Eligibility

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

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
  • Acute or chronic liver disease
  • Patients taking Coumadin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056446

  Show 251 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Bayer
Investigators
Study Chair: Novartis/Schering AG, Germany Novartis / Schering AG Germany
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00056446     History of Changes
Obsolete Identifiers: NCT00068679
Other Study ID Numbers: CPTK787 0133/304946
Study First Received: March 13, 2003
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Levoleucovorin
 Oxaliplatin
Vatalanib
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013