Phase 2
N=215
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00278889 ↗Enrolled (actual)
215
Serious AEs
45.6%
Results posted
Oct 2012
Primary outcome: Primary: Progression Free Survival — 5.8; 7.2; 7.8 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD2171 (Drug); 5-fluorouracil (Drug); Leucovorin (Drug); Oxaliplatin (Drug); Bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2007
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 | — |
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
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.