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

Sponsor:	Novartis Pharmaceuticals
Collaborator:	Bayer
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00056446

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Oxaliplatin Vatalanib Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00056446 History of Changes
Obsolete Identifiers:	NCT00068679
Other Study ID Numbers:	CPTK787 0133/304946
Study First Received:	March 13, 2003
Last Updated:	November 18, 2009
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

Additional relevant MeSH terms:

Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Levoleucovorin

Oxaliplatin
Vatalanib
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012