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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

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ClinicalTrials.gov Identifier: NCT00056446
Recruitment Status : Completed
First Posted : March 14, 2003
Last Update Posted : March 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms Drug: Vatalanib Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 855 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2003
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Overall survival [ Time Frame: throughout duration of study ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: throughout duration of study ]
  2. Time to progression [ Time Frame: throughout duration of study ]
  3. Time to treatment failure [ Time Frame: throughout duration of study ]
  4. Tumor response rate [ Time Frame: throughout duration of study ]
  5. Tolerability and safety profile [ Time Frame: throughout duration of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056446


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

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00056446     History of Changes
Obsolete Identifiers: NCT00068679
Other Study ID Numbers: CPTK787 0133/304946
First Posted: March 14, 2003    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: January 2016

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

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Vatalanib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action