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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Leucovorin; Drug: Oxaliplatin; Drug: AZD2171; Drug: Bevacizumab; Drug: 5-fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00278889

D8480C00041

HORIZON I

EUDRACT number 2005-003443-31

Details and patient eligibility

About

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

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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215 participants in 2 patient groups

1

Active Comparator group

Description:

Bevacizumab + FOLFOX

Treatment:

Drug: 5-fluorouracil

Drug: Leucovorin

Drug: Bevacizumab

Drug: Oxaliplatin

2

Experimental group

Description:

AZD2171 + FOLFOX

Treatment:

Drug: 5-fluorouracil

Drug: Leucovorin

Drug: AZD2171

Drug: Oxaliplatin