Clinical trial NCT00399035: Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer
Official title: A Randomised, Double-blind, Phase III Study to Compare the Efficacy and Safety of Cediranib (AZD2171, RECENTIN™) When Added to 5 Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX) or Capecitabine and Oxaliplatin (XELOX) With the Efficacy and Safety of Placebo When Added to FOLFOX or XELOX in Patients With Previously Untreated Metastatic Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal Cancer
Cediranib
RECENTIN
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 1254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Written Informed Consent
* Carcinoma of the colon or rectum
* One or more measurable lesions

Exclusion Criteria:

* Adjuvant/neoadjuvant therapy within 6-12 months of study entry
* Untreated unstable brain or meningeal metastases
* Specific laboratory ranges
* Specific cardiovascular problems
* Participation in other trials within 30 days

Primary outcomes:
measure: Progression-free Survival
timeFrame: RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.
measure: Overall Survival
timeFrame: Baseline through to date of death upto and including data cut off date of 21/03/10
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Baseline through to date of death upto and including data cut off date of 21/03/10
measure: Best Percentage Change in Tumour Size
timeFrame: Baseline through to date of death upto and including data cut off date of 21/03/10
measure: Duration of Response
timeFrame: Treatment period from initial response up until data cut-off date of 21/03/10
measure: Rate of Resection of Liver Metastases
timeFrame: Post-randomisation until end of study
measure: Time to Wound Healing Complications
timeFrame: Post-randomisation until end of study
Other outcomes:
Locations:
city: Buenos Aires City
country: Argentina
facility: Research Site
city: Capital Federal
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Córdoba
country: Argentina
facility: Research Site
city: Resistencia
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Ashford
country: Australia
facility: Research Site
city: Camperdown
country: Australia
facility: Research Site
city: Heidelberg
country: Australia
facility: Research Site
city: Hornsby
country: Australia
facility: Research Site
city: Liverpool
country: Australia
facility: Research Site
city: Waratah
country: Australia
facility: Research Site
city: Wodonga
country: Australia
facility: Research Site
city: Curitiba
country: Brazil
facility: Research Site
city: Goiânia
country: Brazil
facility: Research Site
city: Jaú
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Salvador
country: Brazil
facility: Research Site
city: Santo André
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Vratza
country: Bulgaria
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: ChongQing
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nanning
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Ceske Budejovice
country: Czech Republic
facility: Research Site
city: Cheb
country: Czech Republic
facility: Research Site
city: Jicin
country: Czech Republic
facility: Research Site
city: Jihlava
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Pribram - Zdabor
country: Czech Republic
facility: Research Site
city: Sumperk
country: Czech Republic
facility: Research Site
city: Zlin
country: Czech Republic
facility: Research Site
city: Znojmo
country: Czech Republic
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Goslar
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Mannheim
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Györ
country: Hungary
facility: Research Site
city: Kecskemét
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Trivandrum
country: India
facility: Research Site
city: Goyang-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Davao City
country: Philippines
facility: Research Site
city: Iloilo
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Quezon
country: Philippines
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Gliwice
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Toruń
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Bellinzona
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Locarno
country: Switzerland
facility: Research Site
city: Zürich
country: Switzerland
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jane Robertson
role: STUDY_DIRECTOR
References:
citation: Smith JC, Brooks L, Hoff PM, McWalter G, Dearden S, Morgan SR, Wilson D, Robertson JD, Jurgensmeier JM. KRAS mutations are associated with inferior clinical outcome in patients with metastatic colorectal cancer, but are not predictive for benefit with cediranib. Eur J Cancer. 2013 Jul;49(10):2424-32. doi: 10.1016/j.ejca.2013.02.023. Epub 2013 Mar 16.