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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms	Drug: Vatalanib	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	855 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
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
Study Start Date :	January 2003
Actual Primary Completion Date :	January 2007
Actual Study Completion Date :	January 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Overall survival [ Time Frame: throughout duration of study ]

Secondary Outcome Measures :

1. Progression free survival [ Time Frame: throughout duration of study ]
2. Time to progression [ Time Frame: throughout duration of study ]
3. Time to treatment failure [ Time Frame: throughout duration of study ]
4. Tumor response rate [ Time Frame: throughout duration of study ]
5. Tolerability and safety profile [ Time Frame: throughout duration of study ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 251 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Bayer

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Results for CPTK787 0133/304946 on the Novartis Clinical Trials Website 

Publications of Results:

Van Cutsem E, Bajetta E, Valle J, Köhne CH, Hecht JR, Moore M, Germond C, Berg W, Chen BL, Jalava T, Lebwohl D, Meinhardt G, Laurent D, Lin E. Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK787/ZK 222584 in patients with previously treated metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):2004-10. doi: 10.1200/JCO.2010.29.5436. Epub 2011 Apr 4.

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00056446 History of Changes
Obsolete Identifiers:	NCT00068679
Other Study ID Numbers:	CPTK787 0133/304946
First Posted:	March 14, 2003
Last Update Posted:	March 6, 2017
Last Verified:	January 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Colorectal Cancer; Oxaliplatin; VEGF inhibitor; Vatalanib; PTK787	Colon Cancer; Colorectal Carcinoma; Rectal Cancer; Colorectal Tumor

Additional relevant MeSH terms:

Neoplasms; Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases	Colonic Diseases; Intestinal Diseases; Rectal Diseases; Oxaliplatin; Vatalanib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action