Phase 3
N=1,614
First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00384176 ↗Enrolled (actual)
1,614
Serious AEs
37.3%
Results posted
Nov 2012
Primary outcome: Primary: Progression Free Survival — 9.9; 10.3 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cediranib (Drug); Bevacizumab (Drug); 5-fluorouracil ( in FOLFOX) (Drug); Leucovorin (in FOLFOX) (Drug); Oxaliplatin (in FOLFOX) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
9.9; 10.3 | — |
| SECONDARY Overall Survival |
22.8; 21.3 | — |
| SECONDARY Objective Response Rate |
328; 337 | — |
| SECONDARY Duration of Response |
8.6; 9.6 | — |
| SECONDARY Percentage Change in Tumour Size |
-23.2; -22.1 | — |
| SECONDARY Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI) |
170; 245 | — |
Summary
The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.
Eligibility Criteria
Inclusion Criteria
- Clinical Diagnosis of colon or rectal cancer
- No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry.
Exclusion Criteria
- Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.
- Poorly controlled hypertension
Data sourced from ClinicalTrials.gov (NCT00384176). 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.