Phase 2
Completed N=215
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
Source: ClinicalTrials.gov NCT00278889 ↗Enrolled (actual)
215
Serious AEs
45.6%
Results posted
Oct 2012
Primary outcomePrimary: Progression Free Survival — 5.8; 7.2; 7.8 Months
Summary
The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
5.8; 7.2; 7.8 | — |
| SECONDARY Objective Response Rate |
13; 14; 18 | — |
| SECONDARY Overall Survival |
14.3; 16.8; 19.6 | — |
| SECONDARY Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI) |
63; 74; 87 | — |
| SECONDARY QOL: Time to Worsening of Treatment-free Survival (TFS) |
98; 112; 147 | — |
| SECONDARY QOL: Time to Worsening of Clear Cell Sarcoma (CCS) |
84; 74; 87 | — |
| SECONDARY QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI) |
106; 92; 155 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of colon or rectal cancer,
- Received prior systemic therapy for cancer,
- Cancer must have progressed during or after first treatment
Exclusion Criteria
- Prior treatment with a VEGF inhibitor,
- Poorly controlled hypertension
Data sourced from ClinicalTrials.gov (NCT00278889). 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.