First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX (HORIZON III)

AstraZeneca

Status and phase: Completed; Phase 3; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Cediranib; Drug: 5-fluorouracil ( in FOLFOX); Drug: Oxaliplatin (in FOLFOX); Drug: Leucovorin (in FOLFOX); Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00384176

D8480C00013

Eudract Number 2005-003440-66

Details and patient eligibility

About

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.

Enrollment: 1,814 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,814 participants in 2 patient groups

1

Active Comparator group

Description:

Bevacizumab + FOLFOX

Treatment:

Drug: Bevacizumab

Drug: Oxaliplatin (in FOLFOX)

Drug: Leucovorin (in FOLFOX)

Drug: 5-fluorouracil ( in FOLFOX)

2

Experimental group

Description:

Cediranib + FOLFOX

Treatment:

Drug: Oxaliplatin (in FOLFOX)

Drug: Leucovorin (in FOLFOX)

Drug: 5-fluorouracil ( in FOLFOX)

Drug: Cediranib