Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

— HORIZON II  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00399035
• Other study ID #: D8480C00051
• Secondary ID: EUDRACT No 2006-
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 13, 2006
• Last updated: July 6, 2016
• Start date: November 2006
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1254
• Est. completion date: January 2017
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 130 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Cediranib
oral tablet
• FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
• XELOX (Capecitabine and Oxaliplatin)
intravenous oxaliplatin 130 mg/ m^2(day 1) followed by oral capecitabine 1,000 mg/ m^2twice daily (day 1 to day 15)
• Cediranib Placebo
oral tablet

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires City
Argentina	Research Site	Capital Federal
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Córdoba
Argentina	Research Site	Resistencia
Argentina	Research Site	Rosario
Argentina	Research Site	Santa Fe
Australia	Research Site	Ashford
Australia	Research Site	Camperdown
Australia	Research Site	Heidelberg
Australia	Research Site	Hornsby
Australia	Research Site	Liverpool
Australia	Research Site	Waratah
Australia	Research Site	Wodonga
Brazil	Research Site	Curitiba
Brazil	Research Site	Goiânia
Brazil	Research Site	Jaú
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Salvador
Brazil	Research Site	Santo André
Brazil	Research Site	Sao Paulo
Brazil	Research Site	São Paulo
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Bulgaria	Research Site	Varna
Bulgaria	Research Site	Veliko Tarnovo
Bulgaria	Research Site	Vratza
China	Research Site	Beijing
China	Research Site	Changchun
China	Research Site	Chengdu
China	Research Site	ChongQing
China	Research Site	Fuzhou
China	Research Site	Guangzhou
China	Research Site	Hangzhou
China	Research Site	Nanjing
China	Research Site	Nanning
China	Research Site	Shanghai
China	Research Site	Tianjin
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Ceske Budejovice
Czech Republic	Research Site	Cheb
Czech Republic	Research Site	Jicin
Czech Republic	Research Site	Jihlava
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Ostrava
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Pribram - Zdabor
Czech Republic	Research Site	Sumperk
Czech Republic	Research Site	Zlin
Czech Republic	Research Site	Znojmo
Germany	Research Site	Essen
Germany	Research Site	Freiburg
Germany	Research Site	Goslar
Germany	Research Site	Hamburg
Germany	Research Site	Hildesheim
Germany	Research Site	Mannheim
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Györ
Hungary	Research Site	Kecskemét
Hungary	Research Site	Nyíregyháza
Hungary	Research Site	Szombathely
Hungary	Research Site	Zalaegerszeg
India	Research Site	Hyderabad
India	Research Site	Trivandrum
Korea, Republic of	Research Site	Goyang-si
Korea, Republic of	Research Site	Seoul
Philippines	Research Site	Cebu City
Philippines	Research Site	Davao City
Philippines	Research Site	Iloilo
Philippines	Research Site	Quezon
Philippines	Research Site	Quezon City
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Gliwice
Poland	Research Site	Kraków
Poland	Research Site	Olsztyn
Poland	Research Site	Torun
Poland	Research Site	Wroclaw
Switzerland	Research Site	Bellinzona
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Locarno
Switzerland	Research Site	Zürich
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
United Kingdom	Research Site	Aberdeen
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Australia,  Brazil,  Bulgaria,  China,  Czech Republic,  Germany,  Hungary,  India,  Korea, Republic of,  Philippines,  Poland,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.	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.	No
Primary	Overall Survival	Number of months from randomisation to the date of death from any cause	Baseline through to date of death upto and including data cut off date of 21/03/10	No
Secondary	Overall Response Rate	Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.RECIST criteria defined as follows: Target lesions Complete Response(CR)Disappearance of all target lesions Partial Response (PR).At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Non-target lesions Complete Response (CR) Disappearance of all non-target lesi	Baseline through to date of death upto and including data cut off date of 21/03/10	No
Secondary	Best Percentage Change in Tumour Size	Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions	Baseline through to date of death upto and including data cut off date of 21/03/10	No
Secondary	Duration of Response	Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.	Treatment period from initial response up until data cut-off date of 21/03/10	No
Secondary	Rate of Resection of Liver Metastases	Number of patients undergoing liver resection, based on patients with liver disease at baseline	Post-randomisation until end of study	No
Secondary	Time to Wound Healing Complications	Number of days from post-randomisation surgery until wound healing complications	Post-randomisation until end of study	No

External Links

•   CSR-D8480C00051.pdf