Official Title: “A Randomized, Double-Blind, Placebo-Controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-Line Chemotherapy With Oxaliplatin/5-Fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2007

Intervention(s) in this Clinical Trial

• Drug: Vatalanib

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Oxaliplatin/5-FU/LV and PTK787/ZK 222584
• Placebo Comparator: 2
  • Oxaliplatin/5-FU/LV and placebo

Primary Measures

• Progression free survival
  • Time Frame: Throughout duration of study
    Safety Issue?: No

Secondary Measures

• Time to progression
  • Time Frame: Throughout duration of study
    Safety Issue?: No
• Time to treatment failure
  • Time Frame: Throughout duration of study
    Safety Issue?: No
• Best overall response rate
  • Time Frame: Throughout duration of study
    Safety Issue?: No
• Tolerability and safety profile
  • Time Frame: Throughout duration of study
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis / Schering AG, Germany Study Chair Novartis / Schering AG, Germany  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00056459

Study ID Number: CPTK787 0135/306241

ClinicalTrials.gov Identifier: NCT00056459

Health Authority: United States: Food and Drug Administration