Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)Drug: XELOX (Capecitabine and Oxaliplatin)
- Registration Number
- NCT00399035
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1254
- Written Informed Consent
- Carcinoma of the colon or rectum
- One or more measurable lesions
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Xelox + placebo Cediranib Cediranib Placebo Xelox + placebo Cediranib FOLFOX + Cediranib Cediranib FOLFOX + Cediranib FOLFOX + Cediranib FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) FOLFOX + Cediranib XELOX + Cediranib Cediranib XELOX + Cediranib XELOX + Cediranib XELOX (Capecitabine and Oxaliplatin) XELOX + Cediranib FOLFOX + placebo Cediranib FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) FOLFOX + placebo Cediranib FOLFOX + placebo Cediranib Cediranib Placebo FOLFOX + placebo Cediranib Xelox + placebo Cediranib XELOX (Capecitabine and Oxaliplatin) Xelox + placebo Cediranib
- Primary Outcome Measures
Name Time Method Overall Survival 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 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 Outcome Measures
Name Time Method Overall Response Rate Baseline through to date of death upto and including data cut off date of 21/03/10 Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.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 lesi
Best Percentage Change in Tumour Size Baseline through to date of death upto and including data cut off date of 21/03/10 Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions
Duration of Response Treatment period from initial response up until data cut-off date of 21/03/10 Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.
Rate of Resection of Liver Metastases Post-randomisation until end of study Number of patients undergoing liver resection, based on patients with liver disease at baseline
Time to Wound Healing Complications Post-randomisation until end of study Number of days from post-randomisation surgery until wound healing complications
Trial Locations
- Locations (1)
Research Site
🇬🇧Manchester, United Kingdom