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A Randomized, Double-blind, Multicenter Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal CancerUnique Data Set IDColorec_AstraZe_2006_78
Clinical Trial Title
A Randomized, Double-blind, Multicenter Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer
Trial Summary and Conditions
With the exception of patients with localised liver metastases that can be resected, the median survival time for patients with metastatic CRC is less than 2 years. There is, therefore, a need to develop novel treatment regimens to improve survival in these patients.This study will demonstrate whether small molecule inhibition of VEGF receptor signaling is a superior anti-angiogenic approach to monoclonal antibody binding of VEGF by comparing the combination of cediranib plus FOLFOX to bevacizumab plus FOLFOX.
Primary and secondary efficacy, safety and demographic data.
The primary objective of the study is to determine:The efficacy of cediranib in combination with 5 fluorouracil (5 FU), leucovorin (or equivalent folinic acid preparation) and oxaliplatin (FOLFOX) compared to the efficacy of bevacizumab in combination with FOLFOX by assessment of progression free survival (PFS).The secondary objectives of the study are to determine:1. The efficacy of cediranib in combination with FOLFOX compared to the efficacy of bevacizumab in combination with FOLFOX by assessment of overall survival (OS), overall response rate (ORR; complete response [CR] + partial response [PR]) and duration of response.2. The safety and tolerability of randomised study therapies in combination with FOLFOX.3. The effects on quality of life (QoL) and disease-related symptoms of cediranib in combination with FOLFOX, compared with the effects of bevacizumab in combination with FOLFOX.
EfficacyPrimary outcome variable: -PFSSecondary outcome variables:-OS-ORR (CR + PR)-Patient reported outcomes (PROs)-Time to worsening of QoL-Time to worsening of disease related symptomsSafety-Adverse events (AEs)-Laboratory findings (clinical chemistry, haematology, urinalysis)-Vital signs-Physical examination including blood pressure (BP)-Electrocardiogram (ECG)
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PROTOCOL: AstraZeneca Study Protocol Cediranib.pdf
CRF: AstraZeneca CRF Cediranib.pdf
DATA (COMPARATOR ARM): AstraZeneca Data Cediranib.xls
Other: AstraZeneca Data Cediranib.zip