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Colorectal

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

Unique Dataset IDColorec_AstraZe_2006_78ClinicalTrial.gov IDNCT00384176
DownloadableYes
SponsorAstraZenecaData ProviderAstraZenecaTotal Study Enrolled Patients1805Comparator (Control) Arm Enrolled Patients690RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugDataset TypeOther

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.

Data Summary

Primary and secondary efficacy, safety and demographic data.

Study Objectives

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.

Outcome Measures

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)

Dataset Linkage

Links to additional datasets associated with this dataset are shown below.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: AstraZeneca Study Protocol Cediranib.pdf

CRF: AstraZeneca CRF Cediranib.pdf

DATA (COMPARATOR ARM): AstraZeneca Data Cediranib.zip

DATA (COMPARATOR ARM): AstraZeneca Data Cediranib.xls