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

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

This study has been completed.

Study NCT00056446. Last updated on October 15, 2008. Information provided by Novartis

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms

Intervention ^†

Drug: Vatalanib

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

855

Start Date ^†

January 2003

Completion Date

October 2004

Eligibility Criteria ^†

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 ^††

Location Countries ^†

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

Administrative Information Fields

NCT ID ^†

NCT00056446

Organization ID

CPTK787 0133/304946

Secondary IDs ^††

Study Sponsor ^†

Novartis Pharmaceuticals

Collaborators ^††

Bayer

Investigators ^†

Study Chair:

Novartis/Schering AG, Germany

Novartis / Schering AG Germany

Information Provided By

Novartis

Verification Date

October 2008

First Received Date ^†

March 13, 2003

Last Updated Date

October 15, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.