A Phase I/II Study of AZD2171 in Japanese Metastatic Colorectal Cancer Patients in Combination With FOLFOX - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00494221

Purpose

This Study is in two parts, the first part is to make sure that combining a potential new treatment (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 AZD2171 tablets and the other will be the standard treatment (FOLFOX) + real 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 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)	Phase I Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Oxaliplatin Cediranib Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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 AZD2171 in Combination With FOLFOX Followed by a Phase II, Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy of AZD2171 in Combination With FOLFOX

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Progression of Metastatic Colorectal Cancer (mCRC) - PFS [ Time Frame: Assessed during treatment and follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	171
Study Start Date:	June 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator FOLFOX + Placebo AZD2171	Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intravenous infusion
2: Experimental FOLFOX + AZD2171	Drug: AZD2171 oral tablet Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) intravenous infusion

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:	Eisei Shin, MD	AstraZeneca

More Information

Additional Information:

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AstraZeneca ( Jane Robertson, MSD )
Study ID Numbers:	D8480C00039
Study First Received:	June 27, 2007
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00494221 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

Colorectal cancer
Recentin
Metastatic Cancer
FOLFOX

Study placed in the following topic categories:

Antimetabolites
Vitamin B Complex
Digestive System Neoplasms
Immunologic Factors
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Trace Elements
Intestinal Diseases
Immunosuppressive Agents

Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Vitamins
Fluorouracil
Neoplasm Metastasis
Gastrointestinal Neoplasms
Micronutrients
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Leucovorin
Rectal Diseases
Neoplasms by Site
Therapeutic Uses
Vitamins

Micronutrients
Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009