Clinical trial · Interventional
Study of Oxaliplatin/5-FU/Leucovorin Plus Vatalanib Versus Oxaliplatin/5-FU/Leucovorin in Patients With Metastatic Colorectal Cancer.
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
NCT00056459CI-TRIAL-00043308completedPhase 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)
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
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
- Progression free survival
- timeFrame
- Throughout duration of study
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHecht JR, Trarbach T, Hainsworth JD, Major P, Jager E, Wolff RA, Lloyd-Salvant K, Bodoky G, Pendergrass K, Berg W, Chen BL, Jalava T, Meinhardt G, Laurent D, Lebwohl D, Kerr D. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):1997-2003. doi: 10.1200/JCO.2010.29.4496. Epub 2011 Apr 4. PMID 21464406