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

Study Overview
=================
Brief Summary
-----------------
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

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

Conditions
-----------------
Colonic Neoplasms, Colorectal Neoplasms, Rectal Neoplasms

Intervention / Treatment
-----------------
* Drug: Vatalanib


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | Throughout duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | Throughout duration of study | 
| Time to treatment failure |  | Throughout duration of study | 
| Best overall response rate |  | Throughout duration of study | 
| Tolerability and safety profile |  | Throughout duration of study | 

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