Clinical trial NCT00494221: A Phase I/II Study of Cediranib (AZD2171) in Japanese Metastatic Colorectal Cancer Patients in Combination With FOLFOX
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal cancer
Recentin
Metastatic Cancer
FOLFOX
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-06-29
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 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)
Secondary outcomes:
measure: Objective Tumour Response Rate
timeFrame: 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)
measure: Best Percentage Change in Tumour Size
timeFrame: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)
measure: Duration of Response
timeFrame: 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)
measure: Overall Survival
timeFrame: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson
role: STUDY_DIRECTOR
affiliation: National Hospital Organization Osaka National Hospital
name: Hideyuki Mishima, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Xiaojin Shi, MD
role: STUDY_CHAIR
References: