Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

March 13, 2003

Last Updated Date

October 15, 2008

Start Date ^ICMJE

January 2003

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall survival [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Overall survival

Change History

Complete list of historical versions of study NCT00056446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression free survival [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
Time to treatment failure [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
Tumor response rate [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
Tolerability and safety profile [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Progression free survival
Time to progression
Time to treatment failure
Tumor response rate
Tolerability and safety profile

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms

Intervention ^ICMJE

Drug: Vatalanib

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

855

Completion Date

October 2004

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hong Kong, Italy, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00056446

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CPTK787 0133/304946

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Bayer

Investigators ^ICMJE

Study Chair:

Novartis/Schering AG, Germany

Novartis / Schering AG Germany

Information Provided By

Novartis

Verification Date

October 2008

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