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

Purpose

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	Intervention	Phase
Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms	Drug: Vatalanib	Phase III

MedlinePlus related topics:

Cancer Colorectal Cancer

Drug Information available for:

Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Vatalanib Butanedioic acid, compd. with N-(4-chlorophenyl)-4-(4-pyridinylmethyl)-1-phthalazinamine (1:1) Fluorouracil Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	855
Study Start Date:	January 2003
Estimated Study Completion Date:	October 2004
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Oxaliplatin/5-FU/LV and PTK787/ZK 222584	Drug: Vatalanib
2: Placebo Comparator Oxaliplatin/5-FU/LV and placebo	Drug: Vatalanib

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056446

Show 251 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Bayer

Investigators


Study Chair:	Novartis/Schering AG, Germany	Novartis / Schering AG Germany

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CPTK787 0133/304946
First Received:	March 13, 2003
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00056446
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Colorectal Cancer

Oxaliplatin

VEGF inhibitor

Vatalanib

PTK787

Colon Cancer

Colorectal Carcinoma

Rectal Cancer

Colorectal Tumor

Study placed in the following topic categories:

Digestive System Neoplasms

Rectal Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Leucovorin

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Vatalanib

Rectal neoplasm

Carcinoma

Oxaliplatin

Digestive System Diseases

Fluorouracil

Gastrointestinal Neoplasms

Adenocarcinoma

Rectal cancer

Colonic Neoplasms

Colorectal Neoplasms

Additional relevant MeSH terms:

Vitamin B Complex

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Vitamins

Therapeutic Uses

Micronutrients

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Novartis Pharmaceuticals Bayer
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00056446