Second Line ColoRectal Cancer Therapy in Combination With FOLFOX - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00278889

Purpose

The primary purpose of this study is to compare the efficacy of AZD2171 in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line treatment of patients with metastatic colorectal cancer

Condition	Intervention	Phase
Colorectal Cancer	Drug: AZD2171 Drug: 5-fluorouracil Drug: Leucovorin Drug: Oxaliplatin Drug: Bevacizumab	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Study to Compare the Efficacy of AZD2171 in Combination With 5-Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX) and the Efficacy of Bevacizumab in Combination With FOLFOX in the Second-Line Treatment of Patients With Metastatic Colorectal Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare the efficacy of AZD2171 in combination with FOLFOX with bevacizumab in combination with FOLFOX. This objective will be assessed by the primary variable of progression free survival (PFS) [ Time Frame: time to progression; time to death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of overall survival (OS) and overall response rate (ORR; complete response [CR] + partial response [PR]). Effects on quality of life (QoL) and disease-related symptoms. The safety and tolerability of study therapies in combination with FOLFOX [ Time Frame: Assessed at each visit until death ] [ Designated as safety issue: No ]

Enrollment:	215
Study Start Date:	January 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Bevacizumab + FOLFOX	Drug: 5-fluorouracil intravenous infusion Drug: Leucovorin intravenous infusion Drug: Oxaliplatin intravenous infusion Drug: Bevacizumab intravenous infusion
2: Experimental AZD2171 + FOLFOX	Drug: AZD2171 oral tablet Drug: 5-fluorouracil intravenous infusion Drug: Leucovorin intravenous infusion Drug: Oxaliplatin intravenous infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of colon or rectal cancer,
Received prior systemic therapy for cancer,
Cancer must have progressed during or after first treatment

Exclusion Criteria:

Prior treatment with a VEGF inhibitor,
Poorly controlled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278889

Show 43 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca AZD2171 Medical Science Director, MD

AstraZeneca

More Information

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

Study ID Numbers:	D8480C00041, EUDRACT number 2005-003443-31, HORIZON I
Study First Received:	January 17, 2006
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00278889
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by AstraZeneca:

Colorectal Cancer
phase II
metastatic colorectal cancer
AZD2171
RECENTIN

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Bevacizumab
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Growth Inhibitors
Angiogenesis Modulating Agents
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009