First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00384176

Purpose

The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX.

Condition	Intervention	Phase
Colorectal Cancer	Drug: Cediranib Drug: Bevacizumab Drug: 5-fluorouracil ( in FOLFOX) Drug: Leucovorin (in FOLFOX) Drug: Oxaliplatin (in FOLFOX)	Phase II Phase III

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, Safety/Efficacy Study
Official Title:	A Randomised, Double-Blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-Fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The efficacy of Cediranib in combination with FOLFOX compared to the efficacy of bevacizumab in combination with FOLFOX by assessment of progression free survival. [ Time Frame: assessed after each visit over 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of overall survival and overall response rate, safety, tolerability and Quality of life when Cediranib is combined with FOLFOX compared to Bevacizumab and FOLFOX [ Time Frame: Assessed during 15 month treatment and 19 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	1600
Study Start Date:	August 2006
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Bevacizumab + FOLFOX	Drug: Bevacizumab intravenous infusion Drug: 5-fluorouracil ( in FOLFOX) intravenous infusion Drug: Leucovorin (in FOLFOX) intravenous infusion Drug: Oxaliplatin (in FOLFOX) intravenous infusion
2: Experimental Cediranib + FOLFOX	Drug: Cediranib oral tablet once daily Drug: 5-fluorouracil ( in FOLFOX) intravenous infusion Drug: Leucovorin (in FOLFOX) intravenous infusion Drug: Oxaliplatin (in FOLFOX) 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
No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry.

Exclusion Criteria:

Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib.
Poorly controlled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384176

Contacts

Contact: AstraZeneca Cancer Study Locator Service	877-400-4656	astrazeneca@emergingmed.com
Contact: Outside US	001-866-992-9276

Show 203 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Nick Botwood, MD

AstraZeneca

More Information

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

US and Canada only This link exits the ClinicalTrials.gov site

Responsible Party:	AstraZeneca ( Nick Botwood / Medical Science Director )
Study ID Numbers:	D8480C00013, Eudract Number 2005-003440-66
Study First Received:	October 3, 2006
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00384176
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Austria: Federal Ministry for Health and Women; Czech Republic: State Institute for Drug Control; Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by AstraZeneca:

Metastatic Colorectal Cancer
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