Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
Conditions
Keywords
Colorectal Cancer, PTK787, Vatalanib, VEGF inhibitor, Oxaliplatin, Angiogenesis, Rectal Cancer, Colon Cancer, Colorectal Carcinoma, Colorectal Tumor
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
Interventions
DRUGVatalanib
Sponsors
Bayer
Novartis
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
* 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 /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | Throughout duration of study |
Secondary
| Measure | 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 |
Countries
Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Outcome results
None listed