A Phase I/II Study of Cediranib (AZD2171) in Japanese Metastatic Colorectal Cancer Patients in Combination With FOLFOX
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00494221
First received: June 27, 2007
Last updated: May 2, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
This Study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal cancer is safe. Once this part is complete and it is decided that it is safe to continue the Study will the go on to look at the efficacy of the two drugs together. This will be done by studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that non-one can tell the difference between the two treatment groups. This kind of study design is done to try to avoid the chance that the results might be biased in some way. The overall aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results. That is, it's better than giving standard treatment alone in helping to prevent progression of mCRC.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Colorectal Cancer |
Drug: AZD2171 Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) Drug: Placebo Cediranib |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Two Part Study in Japanese Patients With mCRC, Consisting of an Open-label Phase I Part to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With FOLFOX Followed by a Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib (AZD2171) in Combination With FOLFOX |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups) ] [ Designated as safety issue: No ]Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Secondary Outcome Measures:
- Objective Tumour Response Rate [ Time Frame: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups) ] [ Designated as safety issue: No ]Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.
- Best Percentage Change in Tumour Size [ Time Frame: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups) ] [ Designated as safety issue: No ]Best percentage change in tumour size from baseline, based on the sum of the longest diameters of the target lesions
- Duration of Response [ Time Frame: RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups) ] [ Designated as safety issue: No ]Number of months from Complete/Partial response until progression up to cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups).
- Overall Survival [ Time Frame: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups) ] [ Designated as safety issue: No ]Number of months until death (censored if still alive at date cut-off). Median non-estimable if >50% of subjects within a group are censored.
| Enrollment: | 172 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: FOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 20 mg
|
Drug: AZD2171
oral tablet
Other Names:
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
|
|
Active Comparator: FOLFOX + Cediranib 30 mg
FOLFOX + Cediranib 30 mg
|
Drug: AZD2171
oral tablet
Other Names:
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
|
|
Placebo Comparator: FOLFOX + Placebo Cediranib
FOLFOX + Placebo Cediranib
|
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
Drug: Placebo Cediranib
oral tablet
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Metastatic colorectal cancer
- WHO performance status 0-1
- Life expectancy is 12 weeks or longer
Exclusion Criteria:
- Patient with uncontrolled brain metastases
- Patient with inappropriate laboratory tests values
- Patient with poorly controlled hypertension
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494221
Locations
| Japan | |
| Research Site | |
| Osaka, Japan | |
| Research Site | |
| Saitama, Japan | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Jane Robertson | AstraZeneca |
| Principal Investigator: | Hideyuki Mishima, M.D., PhD | National Hospital Organization Osaka National Hospital |
| Study Chair: | Xiaojin Shi, MD | AstraZeneca |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00494221 History of Changes |
| Other Study ID Numbers: | D8480C00039 |
| Study First Received: | June 27, 2007 |
| Results First Received: | March 28, 2012 |
| Last Updated: | May 2, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by AstraZeneca:
|
Colorectal cancer Recentin Metastatic Cancer FOLFOX |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Leucovorin Levoleucovorin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013