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Trial record 93 of 127 for:    colon cancer | ( Map: Canada )

Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated 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: NCT00056446
Recruitment Status : Completed
First Posted : March 14, 2003
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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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
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

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. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00056446

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Chair: Novartis/Schering AG, Germany Novartis / Schering AG Germany

Additional Information:
Publications of Results:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00056446    
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
VEGF inhibitor
Colon Cancer
Colorectal Carcinoma
Rectal Cancer
Colorectal Tumor
Additional relevant MeSH terms:
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Colorectal Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action