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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00278889
Acronym
HORIZON I
Enrollment
215
Registered
2006-01-19
Start date
2006-01-31
Completion date
2009-10-31
Last updated
2012-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer, phase II, metastatic colorectal cancer, AZD2171, RECENTIN

Brief summary

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

Interventions

DRUGAZD2171

oral tablet

DRUG5-fluorouracil

intravenous infusion

DRUGLeucovorin

intravenous infusion

DRUGOxaliplatin

intravenous infusion

DRUGBevacizumab

intravenous infusion

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Progression Free SurvivalRandomisation to data cut-off date of November 2007Number of months from randomisation to the earlier date of objective progression or death

Secondary

MeasureTime frameDescription
Overall SurvivalRandomisation to data cut-off date of 30 January 2009Number of months from randomisation to the date of death from any cause
Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)Randomisation to data cut-off date of November 2007Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires
Objective Response RateRandomisation to data cut-off date of November 2007Per 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.
QOL: Time to Worsening of Clear Cell Sarcoma (CCS)Randomisation to data cut-off date of November 2007Time 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)Randomisation to data cut-off date of November 2007Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires
QOL: Time to Worsening of Treatment-free Survival (TFS)Randomisation to data cut-off date of November 2007Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires

Countries

Austria, Belgium, Canada, Czechia, France, Germany, Italy, Spain, United Kingdom

Participant flow

Participants by arm

ArmCount
FOLFOX + Cediranib 20 mg
FOLFOX + Cediranib 20 mg
71
FOLFOX + Cediranib 30 mg
FOLFOX + Cediranib 30 mg
73
FOLFOX + Bevacizumab 10 mg/kg
FOLFOX + Bevacizumab 10 mg/kg
66
Total210

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath242117
Overall StudyLost to Follow-up110
Overall StudyWithdrawal by Subject053

Baseline characteristics

CharacteristicFOLFOX + Cediranib 20 mgFOLFOX + Cediranib 30 mgFOLFOX + Bevacizumab 10 mg/kgTotal
Age Continuous
Age
63.9 Years
STANDARD_DEVIATION 8.7
63.5 Years
STANDARD_DEVIATION 9.6
61.8 Years
STANDARD_DEVIATION 10.6
63.07 Years
STANDARD_DEVIATION 9.63
Sex: Female, Male
Female
22 Participants26 Participants27 Participants75 Participants
Sex: Female, Male
Male
49 Participants47 Participants39 Participants135 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
69 / 7373 / 7466 / 68
serious
Total, serious adverse events
30 / 7339 / 7429 / 68

Outcome results

Primary

Progression Free Survival

Number of months from randomisation to the earlier date of objective progression or death

Time frame: Randomisation to data cut-off date of November 2007

ArmMeasureValue (MEDIAN)
FOLFOX + Cediranib 20 mgProgression Free Survival5.8 Months
FOLFOX + Cediranib 30 mgProgression Free Survival7.2 Months
FOLFOX + Bevacizumab 10 mg/kgProgression Free Survival7.8 Months
Secondary

Objective Response Rate

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.

Time frame: Randomisation to data cut-off date of November 2007

ArmMeasureValue (NUMBER)
FOLFOX + Cediranib 20 mgObjective Response Rate13 Participants
FOLFOX + Cediranib 30 mgObjective Response Rate14 Participants
FOLFOX + Bevacizumab 10 mg/kgObjective Response Rate18 Participants
Secondary

Overall Survival

Number of months from randomisation to the date of death from any cause

Time frame: Randomisation to data cut-off date of 30 January 2009

ArmMeasureValue (MEDIAN)
FOLFOX + Cediranib 20 mgOverall Survival14.3 Months
FOLFOX + Cediranib 30 mgOverall Survival16.8 Months
FOLFOX + Bevacizumab 10 mg/kgOverall Survival19.6 Months
Secondary

QOL: Time to Worsening of Clear Cell Sarcoma (CCS)

Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

Time frame: Randomisation to data cut-off date of November 2007

ArmMeasureValue (MEDIAN)
FOLFOX + Cediranib 20 mgQOL: Time to Worsening of Clear Cell Sarcoma (CCS)84 Days
FOLFOX + Cediranib 30 mgQOL: Time to Worsening of Clear Cell Sarcoma (CCS)74 Days
FOLFOX + Bevacizumab 10 mg/kgQOL: Time to Worsening of Clear Cell Sarcoma (CCS)87 Days
Secondary

QOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)

Time when a sustained clinically important deterioration in CCS has been recorded: derived from the FACT-C questionnaires

Time frame: Randomisation to data cut-off date of November 2007

ArmMeasureValue (MEDIAN)
FOLFOX + Cediranib 20 mgQOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)106 Days
FOLFOX + Cediranib 30 mgQOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)92 Days
FOLFOX + Bevacizumab 10 mg/kgQOL: Time to Worsening of FACT Colorectal Cancer Symptom Index(FCSI)155 Days
Secondary

QOL: Time to Worsening of Treatment-free Survival (TFS)

Time when a sustained clinically important deterioration in TFS has been recorded: derived from the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaires

Time frame: Randomisation to data cut-off date of November 2007

ArmMeasureValue (MEDIAN)
FOLFOX + Cediranib 20 mgQOL: Time to Worsening of Treatment-free Survival (TFS)98 Days
FOLFOX + Cediranib 30 mgQOL: Time to Worsening of Treatment-free Survival (TFS)112 Days
FOLFOX + Bevacizumab 10 mg/kgQOL: Time to Worsening of Treatment-free Survival (TFS)147 Days
Secondary

Quality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)

Time when a sustained clinically important deterioration in TOI has been recorded: derived from the FACT-C questionnaires

Time frame: Randomisation to data cut-off date of November 2007

ArmMeasureValue (MEDIAN)
FOLFOX + Cediranib 20 mgQuality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)63 Days
FOLFOX + Cediranib 30 mgQuality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)74 Days
FOLFOX + Bevacizumab 10 mg/kgQuality Of Live(QOL) : Time to Worsening of Tissue Oxygen Index (TOI)87 Days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026