Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
Conditions
Keywords
Colorectal Cancer, Oxaliplatin, VEGF inhibitor, Vatalanib, PTK787, Colon Cancer, Colorectal Carcinoma, Rectal Cancer, Colorectal Tumor
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.
Interventions
DRUGVatalanib
Sponsors
Bayer
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | throughout duration of study |
Secondary
| Measure | 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 |
Countries
Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hong Kong, Italy, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Outcome results
None listed