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

AstraZeneca logo

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

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

Trial contacts and locations

91

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Data sourced from clinicaltrials.gov

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