Phase 2
Completed N=104
A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer
Colorectal · Cancer
Source: ClinicalTrials.gov NCT00500292 ↗
Enrolled (actual)
104
Serious AEs
19.2%
Results posted
May 2011
Primary outcomePrimary: Number of Patients With an Objective Disease Progression Event — 23; 27; 24 Participants
Summary
The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With an Objective Disease Progression Event |
23; 27; 24 | — |
Eligibility Criteria
Inclusion Criteria
- Progression on or following treatment for metastatic colorectal cancer
- Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
- Have World Health Organisation (WHO) performance status 0-2 and life expectancy >12 weeks
Exclusion Criteria
- Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)
- Previous adjuvant therapy with irinotecan within 12 months of randomisation
- More than one prior course of chemotherapy for treatment of metastatic colorectal cancer
Data sourced from ClinicalTrials.gov (NCT00500292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.