Trial · NCT00384176

First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX

NCT00384176, Phase 2, Phase 3, Completed, AstraZeneca; results first posted 2012-11-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX. Trials, record NCT00384176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00384176

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: First Line Metastatic Colorectal Cancer Therapy in Combination With FOLFOX
NCT number: NCT00384176
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 1,814 participants, actual
Lead sponsor: AstraZeneca
Conditions: Colorectal Cancer
Interventions: Cediranib, Bevacizumab, 5-fluorouracil ( in FOLFOX), Leucovorin (in FOLFOX), Oxaliplatin (in FOLFOX)
First posted: 2006-10-05
Last updated: 2017-04-14
Other registries' IDs: eudract:2005-003440-66
Results first posted: 2012-11-28

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival	Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression	Progression is defined as the number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Secondary	Overall Survival	Randomisation until data cut-off	Number of months from randomisation to the date of death from any cause
Secondary	Objective Response Rate	Up until data cut-off	Objective response rate is Complete Response (CR) + Partial Response (PR) as defined below: CR = Disappearance of all target lesions. PR = At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs.
Secondary	Duration of Response	Up until data cut-off date of 15/11/2007	Duration of Response is calculated as the time from the first recording of CR/PR until the patient progresses, regardless of whether the patient was still taking study medication. Only confirmed responses are included in the calculation. For patients who had not progressed, the end date used in the calculation of duration of response is the data cut-off date of 15th November 2009.
Secondary	Percentage Change in Tumour Size	Baseline to Week 8	Percentage change in tumour size from baseline to first RECIST assessment (Week 8) ((Week 8 - baseline)/baseline)\*100
Secondary	Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)	Baseline through to data cut-off	Time to worsening of symptoms, as measured by the FACT colorectal symptom index (FCSI), will be defined as the time when a sustained clinically important deterioration in the total score from the FCSI has been recorded.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival	Baseline then at Weeks 8, 16, 24 and then every 12 weeks until progression	Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.	Months	MEDIAN
SECONDARY	Overall Survival	Randomisation until data cut-off	Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.	Months	MEDIAN
SECONDARY	Objective Response Rate	Up until data cut-off	Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.	Participants	NUMBER
SECONDARY	Duration of Response	Up until data cut-off date of 15/11/2007	Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation. The decision was taken to continue with cediranib 20 mg. No statistical analyses were performed on the 30mg group.	Months	MEDIAN
SECONDARY	Percentage Change in Tumour Size	Baseline to Week 8	No statistical analyses were performed on the 30mg group. Patients had to have both a baseline and post-baseline (week 8) value to be included in the analysis. If patients did not have a week 8 assessment they were not included.	Percentage change in tumour size	MEAN
SECONDARY	Time to Worsening of Health Related Quality of Life (QOL) Based on the FACT Colorectal Symptom Index (FCSI)	Baseline through to data cut-off		Days	MEDIAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival	Cediranib 20 mg	9.9	Inter-Quartile Range 6.3 to 13.5	Months
Progression Free Survival	Bevacizumab 5 mg/kg	10.3	Inter-Quartile Range 6.5 to 14.1	Months
Overall Survival	Cediranib 20 mg	22.8	Inter-Quartile Range 13.3 to 32.3	Months
Overall Survival	Bevacizumab 5 mg/kg	21.3	Inter-Quartile Range 12.2 to 32.8	Months
Objective Response Rate	Cediranib 20 mg	328		Participants
Objective Response Rate	Bevacizumab 5 mg/kg	337		Participants
Duration of Response	Cediranib 20 mg	8.6	Inter-Quartile Range 6.1 to 12.1	Months
Duration of Response	Bevacizumab 5 mg/kg	9.6	Inter-Quartile Range 6.5 to 13.6	Months
Percentage Change in Tumour Size	Cediranib 20 mg	-23.2	Standard Deviation 21.8	Percentage change in tumour size
Percentage Change in Tumour Size	Bevacizumab 5 mg/kg	-22.1	Standard Deviation 19.55	Percentage change in tumour size

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cediranib 20 mg	709
Overall Study	STARTED	Bevacizumab 5 mg/kg	713
Overall Study	STARTED	Cediranib 30 mg	192
Overall Study	COMPLETED	Cediranib 20 mg	397
Overall Study	COMPLETED	Bevacizumab 5 mg/kg	394
Overall Study	COMPLETED	Cediranib 30 mg	60
Overall Study	NOT COMPLETED	Cediranib 20 mg	312
Overall Study	NOT COMPLETED	Bevacizumab 5 mg/kg	319
Overall Study	NOT COMPLETED	Cediranib 30 mg	132

Source ClinicalTrials.gov

Adverse events1,080

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Neutropenia	Blood and lymphatic system disorders	Cediranib 20 mg	302	705
other	Neutropenia	Blood and lymphatic system disorders	Cediranib 30 mg	85	191
other	Neutropenia	Blood and lymphatic system disorders	1Bevacizumab 5mg/kg	228	704
other	Thrombocytopenia	Blood and lymphatic system disorders	Cediranib 20 mg	186	705
other	Thrombocytopenia	Blood and lymphatic system disorders	Cediranib 30 mg	55	191
other	Thrombocytopenia	Blood and lymphatic system disorders	1Bevacizumab 5mg/kg	85	704
other	Anaemia	Blood and lymphatic system disorders	Cediranib 20 mg	50	705
other	Anaemia	Blood and lymphatic system disorders	Cediranib 30 mg	16	191
other	Anaemia	Blood and lymphatic system disorders	1Bevacizumab 5mg/kg	79	704
other	Leukopenia	Blood and lymphatic system disorders	Cediranib 20 mg	56	705

1 to 10 of 1,080Source ClinicalTrials.gov

See all 1,080 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cediranib 20 mg
Total, all-cause mortality	Cediranib 30 mg
Total, all-cause mortality	1Bevacizumab 5mg/kg
Total, other adverse events	Cediranib 20 mg	684	705
Total, other adverse events	Cediranib 30 mg	187	191
Total, other adverse events	1Bevacizumab 5mg/kg	672	704
Total, serious adverse events	Cediranib 20 mg	275	705
Total, serious adverse events	Cediranib 30 mg	90	191
Total, serious adverse events	1Bevacizumab 5mg/kg	231	704

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19203899	DERIVED	PubMed
30679026	DERIVED	PubMed
31378656	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00384176

GET https://conductscience.org/api/trials/v1/NCT00384176/events?page=2

API reference For AI assistants