Trial · NCT00457691

Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

NCT00457691, Phase 3, Completed, Pfizer; results first posted 2011-06-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer. Trials, record NCT00457691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00457691

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Trial

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

Title: Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
NCT number: NCT00457691
Status: Completed
Phases: Phase 3
Enrollment: 768 participants, actual
Lead sponsor: Pfizer
Conditions: Metastatic Colorectal Cancer
Interventions: 5 fluorouracil, irinotecan, levo- leucovorin, sunitinib, 5 fluorouracil, irinotecan, levo- leucovorin, placebo
First posted: 2007-04-06
Last updated: 2015-03-30
Results first posted: 2011-06-03

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	First dose of study treatment up to 30 months	PFS defined as time from date of randomization to date of first documentation of objective tumour progression or death due to any cause, whichever occurred first.
Secondary	Overall Survival (OS)	Baseline up to 30 months	OS was defined as the time from randomization to the date of death due to any cause. OS data were censored on the day following the date of the last contact at which the patient was known to be alive.
Secondary	Number of Participants With Overall Confirmed Objective Response	Day 28 of Cycle 1 up to 30 months	Objective disease response: participants with a confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Secondary	Duration of Response (DR)	Day 28 of Cycle 1 up to 30 months	DR was defined as the time from the first objective documentation of CR or PR that was subsequently confirmed to the first documentation of disease progression or to death due to any cause, whichever occurred first.
Secondary	Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal	Symptom Intensity score is comprised of the sum of 13 MDASI core items (ie, pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness or tingling). Participant asked to rate severity of each symptom at their worst in past 24 hours; each item rated from 0 to 10, with 0=symptom not present and 10=as bad as you can imagine; lower scores indicated better outcome (range: 0 to 130).
Secondary	Change From Baseline in MDASI-GI Symptom Interference Score	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal	Symptom Interference score is comprised of the sum 6 function items from MDASI core (general activity, walking, work, mood, relations with other people, and enjoyment of life). Participant asked to rate how much symptoms have interfered in past 24 hours; each item rated from 0 to 10, with 0=did not interfere and 10=interfered completely; lower scores indicated better outcome (range: 0 to 60).
Secondary	Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal	EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problem); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed and results in total score range -1.11 to 1.000; higher score indicates better health state.
Secondary	Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal	EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS)	First dose of study treatment up to 30 months	Intent-to-treat (ITT) population included all participants who were randomized.	Weeks	MEDIAN
SECONDARY	Overall Survival (OS)	Baseline up to 30 months	ITT Population.	Weeks	MEDIAN
SECONDARY	Number of Participants With Overall Confirmed Objective Response	Day 28 of Cycle 1 up to 30 months		Participants	NUMBER
SECONDARY	Duration of Response (DR)	Day 28 of Cycle 1 up to 30 months	ITT Population (participants with a confirmed objective tumor response).	Weeks	MEDIAN
SECONDARY	Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal	ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, and 11).	Scores on a scale	MEAN
SECONDARY	Change From Baseline in MDASI-GI Symptom Interference Score	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal	ITT population. The change from baseline MDASI-GI within each treatment arm was evaluated only for those cycles where at least 10 participants had available data (Cycles 2, 3, 5, 7, 9, 11).	scores on a scale	MEAN
SECONDARY	Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal	ITT population. The EQ-5D health state index results were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).	Scores on a scale	MEAN
SECONDARY	Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)	Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal	ITT population. The change from baseline scores for EQ-VAS were assessed for only those cycles where at least 10 participants on either treatment arm had available data (Cycles 2, 3, 5, 7, 9, and 11).	Scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group56

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

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS)	FOLFIRI + Sunitinib		33.6	95% Confidence Interval 30.80 to 36.60	Weeks
Progression-free Survival (PFS)	FOLFIRI + Placebo		36.6	95% Confidence Interval 32.90 to 40.00	Weeks
Overall Survival (OS)	FOLFIRI + Sunitinib		87.9	95% Confidence Interval 75.20 to NA	Weeks
Overall Survival (OS)	FOLFIRI + Placebo		85.9	95% Confidence Interval 81.10 to NA	Weeks
Number of Participants With Overall Confirmed Objective Response	FOLFIRI + Sunitinib		124		Participants
Number of Participants With Overall Confirmed Objective Response	FOLFIRI + Placebo		128		Participants
Duration of Response (DR)	FOLFIRI + Sunitinib		30.1	95% Confidence Interval 27.10 to 37.20	Weeks
Duration of Response (DR)	FOLFIRI + Placebo		39.0	95% Confidence Interval 31.90 to 49.00	Weeks
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score	FOLFIRI + Sunitinib	Cycle 2, Day 1	1.7	95% Confidence Interval -0.4 to 3.8	Scores on a scale
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score	FOLFIRI + Placebo	Cycle 2, Day 1	0.4	95% Confidence Interval -1.3 to 2.2	Scores on a scale

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	FOLFIRI + Sunitinib	386
Overall Study	STARTED	FOLFIRI + Placebo	382
Overall Study	COMPLETED	FOLFIRI + Sunitinib	0
Overall Study	COMPLETED	FOLFIRI + Placebo	0
Overall Study	NOT COMPLETED	FOLFIRI + Sunitinib	386
Overall Study	NOT COMPLETED	FOLFIRI + Placebo	382

Source ClinicalTrials.gov

Adverse events468

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	Anaemia	Blood and lymphatic system disorders	FOLFIRI + Sunitinib	120	384
other	Anaemia	Blood and lymphatic system disorders	FOLFIRI + Placebo	74	379
other	Leukopenia	Blood and lymphatic system disorders	FOLFIRI + Sunitinib	107	384
other	Leukopenia	Blood and lymphatic system disorders	FOLFIRI + Placebo	49	379
other	Neutropenia	Blood and lymphatic system disorders	FOLFIRI + Sunitinib	315	384
other	Neutropenia	Blood and lymphatic system disorders	FOLFIRI + Placebo	188	379
other	Thrombocytopenia	Blood and lymphatic system disorders	FOLFIRI + Sunitinib	129	384
other	Thrombocytopenia	Blood and lymphatic system disorders	FOLFIRI + Placebo	21	379
other	Abdominal distension	Gastrointestinal disorders	FOLFIRI + Sunitinib	21	384
other	Abdominal distension	Gastrointestinal disorders	FOLFIRI + Placebo	26	379

1 to 10 of 468Source ClinicalTrials.gov

See all 468 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	FOLFIRI + Sunitinib
Total, all-cause mortality	FOLFIRI + Placebo
Total, other adverse events	FOLFIRI + Sunitinib	382	384
Total, other adverse events	FOLFIRI + Placebo	362	379
Total, serious adverse events	FOLFIRI + Sunitinib	170	384
Total, serious adverse events	FOLFIRI + Placebo	111	379

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23358972	DERIVED

Source 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 comparisons2

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

Comparison	Source
FOLFIRI + Sunitinib vs FOLFIRI + Placebo: Number of Participants With Overall Confirmed Objective Response	Trial comparisons
FOLFIRI + Sunitinib vs FOLFIRI + Placebo: serious adverse events	Trial comparisons

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/NCT00457691

GET https://conductscience.org/api/trials/v1/NCT00457691/results?page=2

API reference For AI assistants