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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00278889
First received: January 17, 2006
Last updated: September 24, 2012
Last verified: September 2012

January 17, 2006
September 24, 2012
January 2006
November 2007   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]
Number of months from randomisation to the earlier date of objective progression or death
To compare the efficacy of AZD2171 in combination with FOLFOX with bevacizumab in combination with FOLFOX. This objective will be assessed by the primary variable of progression free survival (PFS)
Complete list of historical versions of study NCT00278889 on ClinicalTrials.gov Archive Site
  • Objective Response Rate [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]

    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.

  • Overall Survival [ Time Frame: Randomisation to data cut-off date of 30 January 2009 ] [ Designated as safety issue: No ]
    Number of months from randomisation to the date of death from any cause
  • Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI) [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]
    Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires
  • QOL: Time to Worsening of Treatment-free Survival (TFS) [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]
    Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires
  • QOL: Time to Worsening of Clear Cell Sarcoma (CCS) [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]
    Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
  • QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI) [ Time Frame: Randomisation to data cut-off date of November 2007 ] [ Designated as safety issue: No ]
    Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
Assessment of overall survival (OS) and overall response rate (ORR; complete response [CR] + partial response [PR]). Effects on quality of life (QoL) and disease-related symptoms. The safety and tolerability of study therapies in combination with FOLFOX
Not Provided
Not Provided
 
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: AZD2171
    oral tablet
    Other Names:
    • cediranib
    • RECENTIN™
  • Drug: 5-fluorouracil
    intravenous infusion
    Other Name: 5-FU
  • Drug: Leucovorin
    intravenous infusion
  • Drug: Oxaliplatin
    intravenous infusion
    Other Name: Eloxatin®
  • Drug: Bevacizumab
    intravenous infusion
    Other Name: Avastin®
  • Active Comparator: 1
    Bevacizumab + FOLFOX
    Interventions:
    • Drug: 5-fluorouracil
    • Drug: Leucovorin
    • Drug: Oxaliplatin
    • Drug: Bevacizumab
  • Experimental: 2
    AZD2171 + FOLFOX
    Interventions:
    • Drug: AZD2171
    • Drug: 5-fluorouracil
    • Drug: Leucovorin
    • Drug: Oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
October 2009
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Italy,   Spain,   United Kingdom
 
NCT00278889
D8480C00041, EUDRACT number 2005-003443-31, HORIZON I
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Jane Robertson AstraZeneca
AstraZeneca
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP