Clinical trial · Interventional
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
NCT00056446CI-TRIAL-00026283completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vatalanib | Drug | Vatalanib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Oxaliplatin/5-FU/LV and PTK787/ZK 222584
- interventionNames
- Drug: Vatalanib
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Oxaliplatin/5-FU/LV and placebo
- interventionNames
- Drug: Vatalanib
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- throughout duration of study
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTVan Cutsem E, Bajetta E, Valle J, Kohne CH, Hecht JR, Moore M, Germond C, Berg W, Chen BL, Jalava T, Lebwohl D, Meinhardt G, Laurent D, Lin E. Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK787/ZK 222584 in patients with previously treated metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):2004-10. doi: 10.1200/JCO.2010.29.5436. Epub 2011 Apr 4. PMID 21464401