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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.
 
ClinicalTrials.gov Identifier: NCT00056459
Recruitment Status : Completed
First Posted : March 14, 2003
Last Update Posted : February 10, 2020
Sponsor:
Collaborator:
Bayer
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE March 13, 2003
First Posted Date  ICMJE March 14, 2003
Last Update Posted Date February 10, 2020
Study Start Date  ICMJE February 2003
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
Progression free survival [ Time Frame: Throughout duration of study ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
  • Time to progression [ Time Frame: Throughout duration of study ]
  • Time to treatment failure [ Time Frame: Throughout duration of study ]
  • Best overall response rate [ Time Frame: Throughout duration of study ]
  • Tolerability and safety profile [ Time Frame: Throughout duration of study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Neoplasms
  • Colonic Neoplasms
  • Rectal Neoplasms
Intervention  ICMJE Drug: Vatalanib
Other Name: PTK787/ZK 222584
Study Arms  ICMJE
  • Experimental: 1
    Oxaliplatin/5-FU/LV and PTK787/ZK 222584
    Intervention: Drug: Vatalanib
  • Placebo Comparator: 2
    Oxaliplatin/5-FU/LV and placebo
    Intervention: Drug: Vatalanib
Publications * Hecht JR, Trarbach T, Hainsworth JD, Major P, Jäger E, Wolff RA, Lloyd-Salvant K, Bodoky G, Pendergrass K, Berg W, Chen BL, Jalava T, Meinhardt G, Laurent D, Lebwohl D, Kerr D. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):1997-2003. doi: 10.1200/JCO.2010.29.4496. Epub 2011 Apr 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2008)
1168
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
1090
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States,   Australia,   Belgium,   Brazil,   Canada,   Czechia,   France,   Germany,   Hungary,   Italy,   Netherlands,   New Zealand,   Portugal,   Slovakia,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00056459
Other Study ID Numbers  ICMJE CPTK787 0135/306241
CONFIRM 1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Bayer
Investigators  ICMJE
Study Chair: Novartis / Schering AG, Germany Novartis / Schering AG, Germany
PRS Account Novartis
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP