A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated Metastatic Colorectal Cancer.
Overview
- Phase
- Phase 3
- Intervention
- FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 1254
- Locations
- 1
- Primary Endpoint
- Overall Survival
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written Informed Consent
- •Carcinoma of the colon or rectum
- •One or more measurable lesions
Exclusion Criteria
- •Adjuvant/neoadjuvant therapy within 6-12 months of study entry
- •Untreated unstable brain or meningeal metastases
- •Specific laboratory ranges
- •Specific cardiovascular problems
- •Participation in other trials within 30 days
Arms & Interventions
FOLFOX + placebo Cediranib
FOLFOX + placebo Cediranib
Intervention: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
FOLFOX + placebo Cediranib
FOLFOX + placebo Cediranib
Intervention: Cediranib Placebo
Xelox + placebo Cediranib
Xelox + placebo Cediranib
Intervention: XELOX (Capecitabine and Oxaliplatin)
Xelox + placebo Cediranib
Xelox + placebo Cediranib
Intervention: Cediranib Placebo
FOLFOX + Cediranib
FOLFOX + Cediranib
Intervention: Cediranib
FOLFOX + Cediranib
FOLFOX + Cediranib
Intervention: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
XELOX + Cediranib
XELOX + Cediranib
Intervention: Cediranib
XELOX + Cediranib
XELOX + Cediranib
Intervention: XELOX (Capecitabine and Oxaliplatin)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: Baseline through to date of death upto and including data cut off date of 21/03/10
Number of months from randomisation to the date of death from any cause
Progression-free Survival
Time Frame: RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.
RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression \[non-PD\]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.
Secondary Outcomes
- Overall Response Rate(Baseline through to date of death upto and including data cut off date of 21/03/10)
- Best Percentage Change in Tumour Size(Baseline through to date of death upto and including data cut off date of 21/03/10)
- Duration of Response(Treatment period from initial response up until data cut-off date of 21/03/10)
- Rate of Resection of Liver Metastases(Post-randomisation until end of study)
- Time to Wound Healing Complications(Post-randomisation until end of study)