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A Phase I/II Study of Cediranib (AZD2171) in Japanese Metastatic Colorectal Cancer Patients in Combination With FOLFOX

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00494221
Recruitment Status : Completed
First Posted : June 29, 2007
Results First Posted : June 5, 2012
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: AZD2171 Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) Drug: Placebo Cediranib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : August 2012
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: FOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 20 mg
 Drug: AZD2171
oral tablet
Other Names:
  • cediranib
  • RECENTIN™

Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
  • Eloxatin®
  • 5-FU
  • Leucovorin
Active Comparator: FOLFOX + Cediranib 30 mg
FOLFOX + Cediranib 30 mg
 Drug: AZD2171
oral tablet
Other Names:
  • cediranib
  • RECENTIN™

Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
  • Eloxatin®
  • 5-FU
  • Leucovorin
Placebo Comparator: FOLFOX + Placebo Cediranib
FOLFOX + Placebo Cediranib
 Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
  • Eloxatin®
  • 5-FU
  • Leucovorin

Drug: Placebo Cediranib
oral tablet


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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 :
  1. 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) ]
    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.

  2. 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) ]
    Best percentage change in tumour size from baseline, based on the sum of the longest diameters of the target lesions

  3. 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) ]
    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).

  4. Overall Survival [ Time Frame: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494221


Locations
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Japan
Research Site
Osaka, Japan
Research Site
Saitama, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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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
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00494221    
Other Study ID Numbers: D8480C00039
First Posted: June 29, 2007    Key Record Dates
Results First Posted: June 5, 2012
Last Update Posted: March 27, 2014
Last Verified: February 2014
Keywords provided by AstraZeneca:
Colorectal cancer
Recentin
Metastatic Cancer
FOLFOX
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Fluorouracil
Oxaliplatin
Cediranib
 Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Protein Kinase Inhibitors
Enzyme Inhibitors