Phase 3
Completed N=1,076
Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00399035 ↗Enrolled (actual)
1,076
Serious AEs
37.6%
Results posted
Oct 2012
Primary outcomePrimary: Progression-free Survival — 8.6; 8.2 Months
Summary
The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
8.6; 8.2 | — |
| PRIMARY Overall Survival |
19.7; 18.9 | — |
| SECONDARY Overall Response Rate |
254; 178 | — |
| SECONDARY Best Percentage Change in Tumour Size |
-42.49; -40.61 | — |
| SECONDARY Duration of Response |
8.5; 6.9 | — |
| SECONDARY Rate of Resection of Liver Metastases |
21; 17 | — |
| SECONDARY Time to Wound Healing Complications |
18; 18 | — |
Eligibility Criteria
Inclusion Criteria
- Written Informed Consent
- Carcinoma of the colon or rectum
- One or more measurable lesions
Exclusion Criteria
- Adjuvant/neoadjuvant therapy within 6-12 months of study entry
- Untreated unstable brain or meningeal metastases
- Specific laboratory ranges
- Specific cardiovascular problems
- Participation in other trials within 30 days
Data sourced from ClinicalTrials.gov (NCT00399035). 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.