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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Cediranib Placebo; Drug: Cediranib; Drug: XELOX (Capecitabine and Oxaliplatin); Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00399035

EUDRACT No 2006-001194-14

HORIZON II

D8480C00051

Details and patient eligibility

About

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.

Enrollment: 1,254 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,254 participants in 4 patient groups, including a placebo group

FOLFOX + placebo Cediranib

Placebo Comparator group

Description:

FOLFOX + placebo Cediranib

Treatment:

Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

Drug: Cediranib Placebo

Xelox + placebo Cediranib

Placebo Comparator group

Description:

Xelox + placebo Cediranib

Treatment:

Drug: Cediranib Placebo

Drug: XELOX (Capecitabine and Oxaliplatin)

FOLFOX + Cediranib

Experimental group

Description:

FOLFOX + Cediranib

Treatment:

Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

Drug: Cediranib

XELOX + Cediranib

Experimental group

Description:

XELOX + Cediranib

Treatment:

Drug: XELOX (Capecitabine and Oxaliplatin)

Drug: Cediranib