Clinical trial NCT00278889: Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
phase II
metastatic colorectal cancer
AZD2171
RECENTIN
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Randomisation to data cut-off date of November 2007
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Randomisation to data cut-off date of November 2007
measure: Overall Survival
timeFrame: Randomisation to data cut-off date of 30 January 2009
measure: Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)
timeFrame: Randomisation to data cut-off date of November 2007
measure: QOL: Time to Worsening of Treatment-free Survival (TFS)
timeFrame: Randomisation to data cut-off date of November 2007
measure: QOL: Time to Worsening of Clear Cell Sarcoma (CCS)
timeFrame: Randomisation to data cut-off date of November 2007
measure: QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)
timeFrame: Randomisation to data cut-off date of November 2007
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Bonheiden
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Ressearch Site
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Moncton
country: Canada
facility: Research Site
state: New Brunswick
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Chomutov
country: Czech Republic
facility: Research Site
city: Nova Ves Pod Plesi
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Saint Herblain
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: La Torretta
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: A Coruña
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Ipswich
country: United Kingdom
facility: Research Site
city: Maidstone
country: United Kingdom
facility: Research Site
city: Newcastle-upon-tyne
country: United Kingdom
facility: Research Site
city: Sutton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson
role: STUDY_DIRECTOR
References: