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

Sponsor:	Novartis
Collaborator:	Bayer
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00056459

Purpose

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

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 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

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:

Progression free survival [ Time Frame: Throughout duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]
Best overall 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:	1168
Study Start Date:	February 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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056459

Show 223 Study Locations

Sponsors and Collaborators

Novartis

Bayer

Investigators

Study Chair:

Novartis / Schering AG, Germany

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Apr 4.

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00056459 History of Changes
Other Study ID Numbers:	CPTK787 0135/306241, CONFIRM 1
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
PTK787
Vatalanib
VEGF inhibitor
Oxaliplatin

Angiogenesis
Rectal Cancer
Colon Cancer
Colorectal Carcinoma
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