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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00056459
Recruitment Status : Completed
First Posted : March 14, 2003
Last Update Posted : November 19, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms Drug: Vatalanib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : February 2003
Primary Completion Date : January 2007

Resource links provided by the National Library of Medicine

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

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

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Throughout duration of study ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Throughout duration of study ]
  2. Time to treatment failure [ Time Frame: Throughout duration of study ]
  3. Best overall response rate [ Time Frame: Throughout duration of study ]
  4. Tolerability and safety profile [ Time Frame: Throughout duration of study ]

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

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

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 identifier (NCT number): NCT00056459

  Show 223 Study Locations
Sponsors and Collaborators
Study Chair: Novartis / Schering AG, Germany Novartis / Schering AG, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Identifier: NCT00056459     History of Changes
Other Study ID Numbers: CPTK787 0135/306241
First Posted: March 14, 2003    Key Record Dates
Last Update Posted: November 19, 2009
Last Verified: November 2009

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

Additional relevant MeSH terms:
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
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action