Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)

Colorectal Cancer Clinical Trial

— HORIZON I  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278889
• Other study ID #: D8480C00041
• Secondary ID: EUDRACT number 2
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2006
• Last updated: September 24, 2012
• Start date: January 2006
• Est. completion date: October 2009

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: October 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• AZD2171
oral tablet
• 5-fluorouracil
intravenous infusion
• Leucovorin
intravenous infusion
• Oxaliplatin
intravenous infusion
• Bevacizumab
intravenous infusion

Locations

Country	Name	City	State
Austria	Research Site	Innsbruck
Austria	Research Site	Wels
Austria	Research Site	Wien
Belgium	Research Site	Bonheiden
Belgium	Ressearch Site	Brussels
Belgium	Research Site	Edegem
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba
Czech Republic	Research Site	Chomutov
Czech Republic	Research Site	Nova Ves Pod Plesi
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Praha
France	Research Site	Montpellier
France	Research Site	Saint Herblain
Germany	Research Site	Berlin
Germany	Research Site	Freiburg
Germany	Research Site	Halle
Germany	Research Site	Hannover
Germany	Research Site	Heidelberg
Germany	Research Site	München
Germany	Research Site	Stuttgart
Italy	Research Site	Genova
Italy	Research Site	La Torretta
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Rozzano
Spain	Research Site	A Coruña
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Valencia
Spain	Research Site	Zaragoza
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Ipswich
United Kingdom	Research Site	Maidstone
United Kingdom	Research Site	Newcastle-upon-tyne
United Kingdom	Research Site	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	Number of months from randomisation to the earlier date of objective progression or death	Randomisation to data cut-off date of November 2007	No
Secondary	Objective Response Rate	Per RECIST Criteria (V1.0) and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= ##% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.; Confirmed Partial Response (PR) or Complete Response (CR) as defined by RECIST.	Randomisation to data cut-off date of November 2007	No
Secondary	Overall Survival	Number of months from randomisation to the date of death from any cause	Randomisation to data cut-off date of 30 January 2009	No
Secondary	Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)	Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires	Randomisation to data cut-off date of November 2007	No
Secondary	QOL: Time to Worsening of Treatment-free Survival (TFS)	Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires	Randomisation to data cut-off date of November 2007	No
Secondary	QOL: Time to Worsening of Clear Cell Sarcoma (CCS)	Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires	Randomisation to data cut-off date of November 2007	No
Secondary	QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)	Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires	Randomisation to data cut-off date of November 2007	No

External Links

•   AstraZeneca Information - Outside of the US
•   Cancer Study Locator (US and Canada only)