Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)

Study Overview
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Brief Summary
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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

Official Title
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A Study to Compare the Efficacy of AZD2171 in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-line Treatment of Patients With Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: AZD2171
* Drug: 5-fluorouracil
* Drug: Leucovorin
* Drug: Oxaliplatin
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Bevacizumab + FOLFOX | Drug: 5-fluorouracil<br>* intravenous infusion<br>* Other names: 5-FU;Drug: Leucovorin<br>* intravenous infusion<br>Drug: Oxaliplatin<br>* intravenous infusion<br>* Other names: Eloxatin®;Drug: Bevacizumab<br>* intravenous infusion<br>* Other names: Avastin®;|
| Experimental: 2<br>AZD2171 + FOLFOX | Drug: AZD2171<br>* oral tablet<br>* Other names: RECENTIN™;Drug: 5-fluorouracil<br>* intravenous infusion<br>* Other names: 5-FU;Drug: Leucovorin<br>* intravenous infusion<br>Drug: Oxaliplatin<br>* intravenous infusion<br>* Other names: Eloxatin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Number of months from randomisation to the earlier date of objective progression or death | Randomisation to data cut-off date of November 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST. | Randomisation to data cut-off date of November 2007 | 
| Overall Survival | Number of months from randomisation to the date of death from any cause | Randomisation to data cut-off date of 30 January 2009 | 
| Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI) | Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires | Randomisation to data cut-off date of November 2007 | 
| QOL: Time to Worsening of Treatment-free Survival (TFS) | Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires | Randomisation to data cut-off date of November 2007 | 
| QOL: Time to Worsening of Clear Cell Sarcoma (CCS) | Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires | Randomisation to data cut-off date of November 2007 | 
| QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI) | Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires | Randomisation to data cut-off date of November 2007 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, phase II, metastatic colorectal cancer, AZD2171, RECENTIN