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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00494221
First received: June 27, 2007
Last updated: February 26, 2014
Last verified: February 2014
  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
Study Completion Date: August 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:
  • 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional 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: February 26, 2014
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 July 29, 2014