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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

Intervention / Treatment
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* Drug: Vatalanib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oxaliplatin/5-FU/LV and PTK787/ZK 222584 | Drug: Vatalanib<br> <br> * Other names: PTK787/ZK 222584;|
| Placebo Comparator: 2<br>Oxaliplatin/5-FU/LV and placebo | Drug: Vatalanib<br> <br> * Other names: PTK787/ZK 222584;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | throughout duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | throughout duration of study | 
| Time to progression |  | throughout duration of study | 
| Time to treatment failure |  | throughout duration of study | 
| Tumor response rate |  | throughout duration of study | 
| Tolerability and safety profile |  | throughout duration of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTK787, Colorectal Cancer, Oxaliplatin, VEGF inhibitor, Vatalanib, Colon Cancer, Colorectal Carcinoma, Rectal Cancer, Colorectal Tumor