| Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Previously Treated Metastatic Colorectal Cancer |
| 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 |
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. |
|
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Overall survival [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ] |
Progression free survival [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
Time to treatment failure [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
Tumor response rate [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]
Tolerability and safety profile [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ] |
Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms |
| Drug: Vatalanib |
|
|
|
| Completed |
| 855 |
| January 2003 |
| October 2004 |
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
|
| Both |
| 18 Years and older |
| No |
|
| United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hong Kong, Italy, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom |
|
| NCT00056446 |
| CPTK787 0133/304946 |
|
| Novartis Pharmaceuticals |
| Bayer |
| Study Chair: |
Novartis/Schering AG, Germany |
Novartis / Schering AG Germany |
|
|
| Novartis |
| October 2008 |
| March 13, 2003 |
| October 15, 2008 |