This study is currently recruiting participants.
Verified by AstraZeneca, June 2008
| Sponsored by: | AstraZeneca |
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00399035 |
PurposeThe 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.
| Condition | Intervention | Phase |
| Metastatic Colorectal Cancer | Drug: Cediranib Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) Drug: XELOX (Capecitabine and Oxaliplatin) | Phase III |
| Genetics Home Reference related topics: | Colorectal Cancer |
| MedlinePlus related topics: | Cancer Colorectal Cancer |
| ChemIDplus related topics: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Capecitabine Fluorouracil Oxaliplatin Cediranib |
U.S. FDA Resources
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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. |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- The efficacy of Cediranib when added to FOLFOX or XELOX compared to the efficacy of FOLFOX or XELOX alone in patients with previously untreated metastatic CRC by assessment of Progression Free Survival and Overall Survival. [ Time Frame: Assessed over 13 months of treatment and 14 months of follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The efficacy of Cediranib when added to FOLFOX/XELOX by assessment of Overall Response Rate and Duration of Response. [ Time Frame: Assessed over 13 months of treatment and 14 months of follow-up ] [ Designated as safety issue: No ]
- Rate of resection of liver metastases. [ Time Frame: Assessed over 13 months of treatment and 14 months of follow-up ] [ Designated as safety issue: No ]
- Incidence of wound healing complications. [ Time Frame: Assessed over 13 months of treatment and 14 months of follow-up ] [ Designated as safety issue: No ]
- Safety of Cediranib. [ Time Frame: Assessed over 13 months of treatment and 14 months of follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1050 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Placebo Comparator FOLFOX + placebo Cediranib | Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intravenous infusion |
| 2: Placebo Comparator Xelox + placebo Cediranib | Drug: XELOX (Capecitabine and Oxaliplatin) intravenous oxaliplatin 130 mg/m(2) (day 1) followed by oral capecitabine 1,000 mg/m(2) twice daily (day 1 to day 15) |
| 3: Experimental FOLFOX + Cediranib | Drug: Cediranib oral tablet Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intravenous infusion |
| 4: Experimental XELOX + Cediranib | Drug: Cediranib oral tablet Drug: XELOX (Capecitabine and Oxaliplatin) intravenous oxaliplatin 130 mg/m(2) (day 1) followed by oral capecitabine 1,000 mg/m(2) twice daily (day 1 to day 15) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00399035
Contacts
Sponsors and Collaborators
Investigators
Contacts
| Contact: AstraZeneca Clinical study Information | 1-800-236-9933 | information.center@astrazeneca.com |
| Contact: AZD2171 Trials Enquiries | AZD2171Trials@astrazeneca.com |
 | Show 95 Study Locations |
Sponsors and Collaborators
| AstraZeneca |
Investigators
| Study Director: | Cediranib Medical Science Director, MD | AstraZeneca |