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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00457691
Recruitment Status : Completed
First Posted : April 6, 2007
Results First Posted : June 3, 2011
Last Update Posted : March 30, 2015
Sponsor:
Information provided by:
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Metastatic Colorectal Cancer
Interventions Drug: 5 fluorouracil
Drug: irinotecan
Drug: levo- leucovorin
Drug: sunitinib
Drug: placebo
Enrollment 768
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo
Hide Arm/Group Description Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle. IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
Period Title: Overall Study
Started 386 382
Completed 0 0
Not Completed 386 382
Reason Not Completed
Adverse Event             4             1
Death             163             148
Protocol Violation             1             3
Lost to Follow-up             23             14
Study terminated by Sponsor             1             1
Subject refused (reason other than AE)             14             19
Disease progression, study terminated             180             196
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo Total
Hide Arm/Group Description Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle. IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle. Total of all reporting groups
Overall Number of Baseline Participants 386 382 768
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 386 participants 382 participants 768 participants
58.6  (10.36) 57.6  (10.77) 58.1  (10.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 386 participants 382 participants 768 participants
Female
164
  42.5%
179
  46.9%
343
  44.7%
Male
222
  57.5%
203
  53.1%
425
  55.3%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description 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.
Time Frame First dose of study treatment up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized.
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo
Hide Arm/Group Description:
Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
Overall Number of Participants Analyzed 386 382
Median (95% Confidence Interval)
Unit of Measure: Weeks
33.6
(30.80 to 36.60)
36.6
(32.90 to 40.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOLFIRI + Sunitinib, FOLFIRI + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8072
Comments p-value from 1-sided log-rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status, organ sites with disease, primary tumor site, prior adjuvant treatment
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.095
Confidence Interval (2-Sided) 95%
0.892 to 1.344
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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.
Time Frame Baseline up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo
Hide Arm/Group Description:
Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
Overall Number of Participants Analyzed 386 382
Median (95% Confidence Interval)
Unit of Measure: Weeks
87.9 [1] 
(75.20 to NA)
85.9 [1] 
(81.10 to NA)
[1]
Upper limit of the confidence interval was not calculable due to the large number of censored events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FOLFIRI + Sunitinib, FOLFIRI + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9163
Comments p-value from 1-sided log-rank test, stratified by ECOG performance status, organ sites with disease, primary tumor site, prior adjuvant treatment
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.171
Confidence Interval (2-Sided) 95%
0.936 to 1.466
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Overall Confirmed Objective Response
Hide Description 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.
Time Frame Day 28 of Cycle 1 up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo
Hide Arm/Group Description:
Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
Overall Number of Participants Analyzed 386 382
Measure Type: Number
Unit of Measure: Participants
124 128
4.Secondary Outcome
Title Duration of Response (DR)
Hide Description 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.
Time Frame Day 28 of Cycle 1 up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population (participants with a confirmed objective tumor response).
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo
Hide Arm/Group Description:
Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
Overall Number of Participants Analyzed 124 128
Median (95% Confidence Interval)
Unit of Measure: Weeks
30.1
(27.10 to 37.20)
39.0
(31.90 to 49.00)
5.Secondary Outcome
Title Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Assessment Inventory of Gastrointestinal Symptoms (MDASI-GI) Symptom Intensity Score
Hide Description 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).
Time Frame Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until end of treatment (EOT)/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo
Hide Arm/Group Description:
Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
Overall Number of Participants Analyzed 386 382
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Cycle 2, Day 1
1.7
(-0.4 to 3.8)
0.4
(-1.3 to 2.2)
Cycle 3, Day 1
0.8
(-1.4 to 2.9)
0.9
(-1.1 to 3.0)
Cycle 5, Day 1
1.0
(-1.6 to 3.7)
1.8
(-0.4 to 3.9)
Cycle 7, Day 1
0.7
(-2.6 to 4.0)
2.7
(-0.3 to 5.7)
Cycle 9, Day 1
0.8
(-5.6 to 7.1)
1.2
(-3.3 to 5.6)
Cycle 11, Day 1
5.0
(-3.2 to 13.2)
-2.7
(-8.4 to 3.0)
6.Secondary Outcome
Title Change From Baseline in MDASI-GI Symptom Interference Score
Hide Description 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).
Time Frame Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo
Hide Arm/Group Description:
Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
Overall Number of Participants Analyzed 386 382
Mean (95% Confidence Interval)
Unit of Measure: scores on a scale
Cycle 2, Day 1
0.0
(-1.4 to 1.4)
-1.3
(-2.6 to 0.0)
Cycle 3, Day 1
-0.1
(-1.8 to 1.6)
-1.7
(-3.2 to -0.2)
Cycle 5, Day 1
0.2
(-1.8 to 2.1)
-1.2
(-3.1 to 0.6)
Cycle 7, Day 1
-0.5
(-2.9 to 1.9)
-0.2
(-2.7 to 2.3)
Cycle 9, Day 1
2.1
(-0.7 to 4.9)
-1.7
(-4.7 to 1.2)
Cycle 11, Day 1
3.1
(-1.2 to 7.4)
-1.0
(-6.5 to 4.5)
7.Secondary Outcome
Title Change From Baseline in European Quality of Life (EuroQol) EQ-5D Self-Report Questionnaire
Hide Description 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.
Time Frame Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo
Hide Arm/Group Description:
Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
Overall Number of Participants Analyzed 386 382
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Cycle 2, Day 1
0.02
(0.00 to 0.04)
0.04
(0.02 to 0.05)
Cycle 3, Day 1
0.02
(0.00 to 0.04)
0.04
(0.02 to 0.06)
Cycle 5, Day 1
0.02
(-0.00 to 0.05)
0.03
(0.01 to 0.05)
Cycle 7, Day 1
0.03
(-0.01 to 0.06)
0.05
(0.02 to 0.07)
Cycle 9, Day 1
0.00
(-0.05 to 0.05)
0.05
(0.02 to 0.08)
Cycle 11, Day 1
0.01
(-0.04 to 0.06)
0.09
(0.05 to 0.14)
8.Secondary Outcome
Title Change From Baseline in EuroQol (EQ) Visual Analog Scale (VAS) (EQ-VAS)
Hide Description 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.
Time Frame Day 1 of Cycles 1-3 and Day 1 of every odd-numbered cycle thereafter until EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo
Hide Arm/Group Description:
Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
Overall Number of Participants Analyzed 386 382
Mean (95% Confidence Interval)
Unit of Measure: Scores on a scale
Cycle 2, Day 1
1.0
(-1.1 to 3.0)
3.3
(1.3 to 5.3)
Cycle 3, Day 1
1.7
(-0.7 to 4.0)
4.3
(2.0 to 6.6)
Cycle 5, Day 1
1.8
(-0.6 to 4.1)
6.6
(3.5 to 9.8)
Cycle 7, Day 1
3.8
(-0.4 to 8.1)
4.3
(0.4 to 8.2)
Cycle 9, Day 1
-0.9
(-6.2 to 4.5)
4.0
(-0.5 to 8.5)
Cycle 11, Day 1
-1.6
(-6.7 to 3.6)
9.0
(2.6 to 15.3)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title FOLFIRI + Sunitinib FOLFIRI + Placebo
Hide Arm/Group Description Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle. IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
All-Cause Mortality
FOLFIRI + Sunitinib FOLFIRI + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
FOLFIRI + Sunitinib FOLFIRI + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   170/384 (44.27%)   111/379 (29.29%) 
Blood and lymphatic system disorders     
Anaemia  1  9/384 (2.34%)  4/379 (1.06%) 
Febrile neutropenia  1  25/384 (6.51%)  11/379 (2.90%) 
Granulocytopenia  1  1/384 (0.26%)  0/379 (0.00%) 
Leukopenia  1  9/384 (2.34%)  3/379 (0.79%) 
Neutropenia  1  26/384 (6.77%)  6/379 (1.58%) 
Pancytopenia  1  2/384 (0.52%)  0/379 (0.00%) 
Thrombocytopenia  1  13/384 (3.39%)  1/379 (0.26%) 
Cardiac disorders     
Acute myocardial infarction  1  1/384 (0.26%)  2/379 (0.53%) 
Atrial fibrillation  1  2/384 (0.52%)  2/379 (0.53%) 
Cardiac arrest  1  1/384 (0.26%)  0/379 (0.00%) 
Cardiac failure  1  0/384 (0.00%)  3/379 (0.79%) 
Cardiac failure congestive  1  1/384 (0.26%)  0/379 (0.00%) 
Cardiopulmonary failure  1  0/384 (0.00%)  1/379 (0.26%) 
Myocardial infarction  1  2/384 (0.52%)  0/379 (0.00%) 
Pericardial effusion  1  0/384 (0.00%)  1/379 (0.26%) 
Ventricular fibrillation  1  0/384 (0.00%)  1/379 (0.26%) 
Ventricular tachycardia  1  1/384 (0.26%)  0/379 (0.00%) 
Ear and labyrinth disorders     
Hearing impaired  1  1/384 (0.26%)  0/379 (0.00%) 
Vertigo  1  1/384 (0.26%)  0/379 (0.00%) 
Endocrine disorders     
Hypothyroidism  1  1/384 (0.26%)  0/379 (0.00%) 
Eye disorders     
Pupils unequal  1  0/384 (0.00%)  1/379 (0.26%) 
Gastrointestinal disorders     
Abdominal adhesions  1  0/384 (0.00%)  1/379 (0.26%) 
Abdominal distension  1  0/384 (0.00%)  1/379 (0.26%) 
Abdominal pain  1  7/384 (1.82%)  6/379 (1.58%) 
Abdominal pain lower  1  0/384 (0.00%)  1/379 (0.26%) 
Abdominal pain upper  1  1/384 (0.26%)  0/379 (0.00%) 
Acute abdomen  1  1/384 (0.26%)  0/379 (0.00%) 
Anal fissure  1  1/384 (0.26%)  0/379 (0.00%) 
Ascites  1  2/384 (0.52%)  2/379 (0.53%) 
Colonic obstruction  1  2/384 (0.52%)  0/379 (0.00%) 
Constipation  1  2/384 (0.52%)  1/379 (0.26%) 
Diarrhoea  1  23/384 (5.99%)  19/379 (5.01%) 
Diarrhoea haemorrhagic  1  1/384 (0.26%)  0/379 (0.00%) 
Duodenal ulcer  1  0/384 (0.00%)  1/379 (0.26%) 
Duodenal ulcer haemorrhage  1  1/384 (0.26%)  0/379 (0.00%) 
Faecaloma  1  1/384 (0.26%)  0/379 (0.00%) 
Gastritis  1  1/384 (0.26%)  2/379 (0.53%) 
Gastritis erosive  1  0/384 (0.00%)  1/379 (0.26%) 
Gastrointestinal haemorrhage  1  3/384 (0.78%)  1/379 (0.26%) 
Gastrointestinal hypomotility  1  1/384 (0.26%)  0/379 (0.00%) 
Gastrooesophagitis  1  1/384 (0.26%)  0/379 (0.00%) 
Haematemesis  1  2/384 (0.52%)  0/379 (0.00%) 
Haematochezia  1  0/384 (0.00%)  1/379 (0.26%) 
Haemorrhoidal haemorrhage  1  0/384 (0.00%)  1/379 (0.26%) 
Haemorrhoids  1  2/384 (0.52%)  0/379 (0.00%) 
Ileus  1  2/384 (0.52%)  8/379 (2.11%) 
Intestinal ischaemia  1  0/384 (0.00%)  1/379 (0.26%) 
Intestinal obstruction  1  8/384 (2.08%)  10/379 (2.64%) 
Intestinal perforation  1  2/384 (0.52%)  0/379 (0.00%) 
Large intestine perforation  1  2/384 (0.52%)  0/379 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/384 (0.00%)  1/379 (0.26%) 
Mechanical ileus  1  1/384 (0.26%)  0/379 (0.00%) 
Mouth ulceration  1  1/384 (0.26%)  0/379 (0.00%) 
Nausea  1  5/384 (1.30%)  4/379 (1.06%) 
Oesophageal ulcer  1  0/384 (0.00%)  1/379 (0.26%) 
Pancreatitis acute  1  1/384 (0.26%)  0/379 (0.00%) 
Peritonitis  1  1/384 (0.26%)  1/379 (0.26%) 
Proctalgia  1  1/384 (0.26%)  0/379 (0.00%) 
Rectal haemorrhage  1  7/384 (1.82%)  1/379 (0.26%) 
Small intestinal obstruction  1  4/384 (1.04%)  2/379 (0.53%) 
Stomatitis  1  2/384 (0.52%)  1/379 (0.26%) 
Subileus  1  1/384 (0.26%)  0/379 (0.00%) 
Vomiting  1  11/384 (2.86%)  11/379 (2.90%) 
General disorders     
Asthenia  1  3/384 (0.78%)  4/379 (1.06%) 
Catheter related complication  1  0/384 (0.00%)  1/379 (0.26%) 
Catheter thrombosis  1  1/384 (0.26%)  0/379 (0.00%) 
Chest pain  1  2/384 (0.52%)  0/379 (0.00%) 
Chills  1  1/384 (0.26%)  1/379 (0.26%) 
Death  1  4/384 (1.04%)  4/379 (1.06%) 
Disease progression  1  12/384 (3.13%)  3/379 (0.79%) 
Fatigue  1  4/384 (1.04%)  1/379 (0.26%) 
General physical health deterioration  1  0/384 (0.00%)  1/379 (0.26%) 
Mucosal inflammation  1  4/384 (1.04%)  0/379 (0.00%) 
Oedema peripheral  1  1/384 (0.26%)  1/379 (0.26%) 
Pain  1  0/384 (0.00%)  1/379 (0.26%) 
Pyrexia  1  17/384 (4.43%)  12/379 (3.17%) 
Hepatobiliary disorders     
Cholecystitis  1  2/384 (0.52%)  0/379 (0.00%) 
Chronic hepatitis  1  1/384 (0.26%)  0/379 (0.00%) 
Hepatic failure  1  0/384 (0.00%)  1/379 (0.26%) 
Hepatic pain  1  0/384 (0.00%)  1/379 (0.26%) 
Hyperbilirubinaemia  1  1/384 (0.26%)  0/379 (0.00%) 
Jaundice cholestatic  1  0/384 (0.00%)  1/379 (0.26%) 
Immune system disorders     
Anaphylactic reaction  1  0/384 (0.00%)  1/379 (0.26%) 
Infections and infestations     
Abdominal abscess  1  0/384 (0.00%)  1/379 (0.26%) 
Abscess  1  2/384 (0.52%)  0/379 (0.00%) 
Anal abscess  1  3/384 (0.78%)  1/379 (0.26%) 
Bacterial infection  1  0/384 (0.00%)  1/379 (0.26%) 
Catheter sepsis  1  0/384 (0.00%)  1/379 (0.26%) 
Cellulitis  1  1/384 (0.26%)  0/379 (0.00%) 
Central line infection  1  4/384 (1.04%)  1/379 (0.26%) 
Cholecystitis infective  1  1/384 (0.26%)  0/379 (0.00%) 
Cystitis  1  1/384 (0.26%)  0/379 (0.00%) 
Empyema  1  1/384 (0.26%)  0/379 (0.00%) 
Escherichia bacteraemia  1  1/384 (0.26%)  0/379 (0.00%) 
Gastroenteritis  1  2/384 (0.52%)  0/379 (0.00%) 
Herpes zoster  1  1/384 (0.26%)  0/379 (0.00%) 
Implant site cellulitis  1  1/384 (0.26%)  0/379 (0.00%) 
Infection  1  2/384 (0.52%)  1/379 (0.26%) 
Liver abscess  1  1/384 (0.26%)  1/379 (0.26%) 
Lower respiratory tract infection  1  2/384 (0.52%)  1/379 (0.26%) 
Lung abscess  1  1/384 (0.26%)  1/379 (0.26%) 
Necrotising fasciitis  1  1/384 (0.26%)  0/379 (0.00%) 
Neutropenic sepsis  1  1/384 (0.26%)  1/379 (0.26%) 
Orchitis  1  1/384 (0.26%)  0/379 (0.00%) 
Perirectal abscess  1  0/384 (0.00%)  1/379 (0.26%) 
Peritonitis bacterial  1  1/384 (0.26%)  0/379 (0.00%) 
Pneumonia  1  5/384 (1.30%)  7/379 (1.85%) 
Pseudomonal sepsis  1  0/384 (0.00%)  1/379 (0.26%) 
Pseudomonas pseudomallei infection  1  0/384 (0.00%)  1/379 (0.26%) 
Retroperitoneal abscess  1  0/384 (0.00%)  1/379 (0.26%) 
Sepsis  1  4/384 (1.04%)  3/379 (0.79%) 
Septic shock  1  1/384 (0.26%)  0/379 (0.00%) 
Subcutaneous abscess  1  1/384 (0.26%)  0/379 (0.00%) 
Tooth infection  1  1/384 (0.26%)  0/379 (0.00%) 
Urinary tract infection  1  2/384 (0.52%)  3/379 (0.79%) 
Urosepsis  1  0/384 (0.00%)  1/379 (0.26%) 
Injury, poisoning and procedural complications     
Fall  1  1/384 (0.26%)  2/379 (0.53%) 
Femoral neck fracture  1  0/384 (0.00%)  1/379 (0.26%) 
Gastrointestinal stoma complication  1  0/384 (0.00%)  1/379 (0.26%) 
Overdose  1  1/384 (0.26%)  0/379 (0.00%) 
Peripancreatic fluid collection  1  1/384 (0.26%)  0/379 (0.00%) 
Post procedural haemorrhage  1  2/384 (0.52%)  0/379 (0.00%) 
Stent occlusion  1  2/384 (0.52%)  0/379 (0.00%) 
Investigations     
Blood creatinine increased  1  0/384 (0.00%)  2/379 (0.53%) 
C-reactive protein increased  1  0/384 (0.00%)  1/379 (0.26%) 
Cardiac stress test abnormal  1  1/384 (0.26%)  0/379 (0.00%) 
Electrocardiogram ST segment depression  1  1/384 (0.26%)  0/379 (0.00%) 
Renal function test abnormal  1  0/384 (0.00%)  1/379 (0.26%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/384 (0.00%)  1/379 (0.26%) 
Dehydration  1  5/384 (1.30%)  4/379 (1.06%) 
Diabetes mellitus  1  1/384 (0.26%)  0/379 (0.00%) 
Diabetic ketoacidosis  1  1/384 (0.26%)  0/379 (0.00%) 
Electrolyte imbalance  1  1/384 (0.26%)  0/379 (0.00%) 
Hyperglycaemia  1  0/384 (0.00%)  3/379 (0.79%) 
Hypochloraemia  1  0/384 (0.00%)  1/379 (0.26%) 
Hypokalaemia  1  2/384 (0.52%)  2/379 (0.53%) 
Hyponatraemia  1  1/384 (0.26%)  1/379 (0.26%) 
Tumour lysis syndrome  1  1/384 (0.26%)  0/379 (0.00%) 
Musculoskeletal and connective tissue disorders     
Monarthritis  1  1/384 (0.26%)  0/379 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  0/384 (0.00%)  1/379 (0.26%) 
Leukoerythroblastosis  1  0/384 (0.00%)  1/379 (0.26%) 
Neoplasm malignant  1  1/384 (0.26%)  0/379 (0.00%) 
Nervous system disorders     
Amnesia  1  1/384 (0.26%)  0/379 (0.00%) 
Ataxia  1  0/384 (0.00%)  1/379 (0.26%) 
Cerebral ischaemia  1  1/384 (0.26%)  0/379 (0.00%) 
Cerebrovascular accident  1  0/384 (0.00%)  1/379 (0.26%) 
Convulsion  1  1/384 (0.26%)  1/379 (0.26%) 
Dizziness  1  0/384 (0.00%)  2/379 (0.53%) 
Haemorrhage intracranial  1  0/384 (0.00%)  1/379 (0.26%) 
Headache  1  2/384 (0.52%)  1/379 (0.26%) 
Hemiparesis  1  0/384 (0.00%)  1/379 (0.26%) 
Ischaemic stroke  1  0/384 (0.00%)  1/379 (0.26%) 
Syncope  1  1/384 (0.26%)  0/379 (0.00%) 
Transient ischaemic attack  1  1/384 (0.26%)  0/379 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/384 (0.26%)  0/379 (0.00%) 
Mental status changes  1  0/384 (0.00%)  1/379 (0.26%) 
Renal and urinary disorders     
Anuria  1  2/384 (0.52%)  0/379 (0.00%) 
Calculus ureteric  1  0/384 (0.00%)  1/379 (0.26%) 
Haematuria  1  2/384 (0.52%)  1/379 (0.26%) 
Hydronephrosis  1  3/384 (0.78%)  3/379 (0.79%) 
Hydroureter  1  1/384 (0.26%)  0/379 (0.00%) 
Renal failure acute  1  2/384 (0.52%)  0/379 (0.00%) 
Renal impairment  1  1/384 (0.26%)  2/379 (0.53%) 
Ureteric obstruction  1  0/384 (0.00%)  1/379 (0.26%) 
Ureteric stenosis  1  0/384 (0.00%)  1/379 (0.26%) 
Reproductive system and breast disorders     
Vaginal haemorrhage  1  1/384 (0.26%)  0/379 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/384 (0.26%)  0/379 (0.00%) 
Cough  1  2/384 (0.52%)  0/379 (0.00%) 
Dyspnoea  1  2/384 (0.52%)  0/379 (0.00%) 
Epistaxis  1  2/384 (0.52%)  0/379 (0.00%) 
Haemoptysis  1  1/384 (0.26%)  0/379 (0.00%) 
Haemothorax  1  0/384 (0.00%)  1/379 (0.26%) 
Pleural effusion  1  0/384 (0.00%)  2/379 (0.53%) 
Pleurisy  1  0/384 (0.00%)  1/379 (0.26%) 
Pneumonia aspiration  1  1/384 (0.26%)  0/379 (0.00%) 
Pneumothorax  1  0/384 (0.00%)  5/379 (1.32%) 
Pulmonary embolism  1  8/384 (2.08%)  8/379 (2.11%) 
Pulmonary oedema  1  1/384 (0.26%)  0/379 (0.00%) 
Respiratory disorder  1  1/384 (0.26%)  0/379 (0.00%) 
Respiratory failure  1  1/384 (0.26%)  0/379 (0.00%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/384 (0.26%)  0/379 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  1/384 (0.26%)  0/379 (0.00%) 
Social circumstances     
Immobile  1  1/384 (0.26%)  0/379 (0.00%) 
Surgical and medical procedures     
Central venous catheter removal  1  0/384 (0.00%)  1/379 (0.26%) 
Vascular disorders     
Axillary vein thrombosis  1  1/384 (0.26%)  0/379 (0.00%) 
Circulatory collapse  1  1/384 (0.26%)  0/379 (0.00%) 
Deep vein thrombosis  1  6/384 (1.56%)  3/379 (0.79%) 
Embolism  1  1/384 (0.26%)  0/379 (0.00%) 
Hypertension  1  2/384 (0.52%)  0/379 (0.00%) 
Hypotension  1  1/384 (0.26%)  3/379 (0.79%) 
Jugular vein thrombosis  1  0/384 (0.00%)  2/379 (0.53%) 
Peripheral ischaemia  1  1/384 (0.26%)  0/379 (0.00%) 
Phlebitis  1  1/384 (0.26%)  0/379 (0.00%) 
Subclavian vein thrombosis  1  1/384 (0.26%)  1/379 (0.26%) 
Thrombophlebitis  1  1/384 (0.26%)  1/379 (0.26%) 
Thrombosis  1  1/384 (0.26%)  1/379 (0.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FOLFIRI + Sunitinib FOLFIRI + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   382/384 (99.48%)   362/379 (95.51%) 
Blood and lymphatic system disorders     
Anaemia  1  120/384 (31.25%)  74/379 (19.53%) 
Leukopenia  1  107/384 (27.86%)  49/379 (12.93%) 
Neutropenia  1  315/384 (82.03%)  188/379 (49.60%) 
Thrombocytopenia  1  129/384 (33.59%)  21/379 (5.54%) 
Gastrointestinal disorders     
Abdominal distension  1  21/384 (5.47%)  26/379 (6.86%) 
Abdominal pain  1  89/384 (23.18%)  73/379 (19.26%) 
Abdominal pain upper  1  43/384 (11.20%)  28/379 (7.39%) 
Constipation  1  89/384 (23.18%)  72/379 (19.00%) 
Diarrhoea  1  247/384 (64.32%)  182/379 (48.02%) 
Dyspepsia  1  45/384 (11.72%)  24/379 (6.33%) 
Nausea  1  190/384 (49.48%)  181/379 (47.76%) 
Stomatitis  1  88/384 (22.92%)  45/379 (11.87%) 
Vomiting  1  144/384 (37.50%)  129/379 (34.04%) 
General disorders     
Asthenia  1  70/384 (18.23%)  65/379 (17.15%) 
Chest pain  1  28/384 (7.29%)  9/379 (2.37%) 
Fatigue  1  120/384 (31.25%)  93/379 (24.54%) 
Mucosal inflammation  1  87/384 (22.66%)  66/379 (17.41%) 
Oedema peripheral  1  27/384 (7.03%)  26/379 (6.86%) 
Pyrexia  1  67/384 (17.45%)  53/379 (13.98%) 
Infections and infestations     
Upper respiratory tract infection  1  24/384 (6.25%)  20/379 (5.28%) 
Investigations     
Alanine aminotransferase increased  1  23/384 (5.99%)  12/379 (3.17%) 
Aspartate aminotransferase increased  1  22/384 (5.73%)  9/379 (2.37%) 
Weight decreased  1  36/384 (9.38%)  17/379 (4.49%) 
Metabolism and nutrition disorders     
Decreased appetite  1  116/384 (30.21%)  82/379 (21.64%) 
Hypokalaemia  1  40/384 (10.42%)  20/379 (5.28%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  37/384 (9.64%)  32/379 (8.44%) 
Nervous system disorders     
Dizziness  1  29/384 (7.55%)  27/379 (7.12%) 
Dysgeusia  1  30/384 (7.81%)  20/379 (5.28%) 
Headache  1  44/384 (11.46%)  28/379 (7.39%) 
Psychiatric disorders     
Insomnia  1  55/384 (14.32%)  48/379 (12.66%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  49/384 (12.76%)  41/379 (10.82%) 
Dyspnoea  1  29/384 (7.55%)  15/379 (3.96%) 
Epistaxis  1  48/384 (12.50%)  21/379 (5.54%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  128/384 (33.33%)  121/379 (31.93%) 
Palmar-plantar erythrodysaesthesia syndrome  1  77/384 (20.05%)  26/379 (6.86%) 
Rash  1  41/384 (10.68%)  32/379 (8.44%) 
Skin discolouration  1  22/384 (5.73%)  2/379 (0.53%) 
Vascular disorders     
Hypertension  1  56/384 (14.58%)  19/379 (5.01%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00457691    
Other Study ID Numbers: A6181122
First Submitted: April 4, 2007
First Posted: April 6, 2007
Results First Submitted: March 9, 2011
Results First Posted: June 3, 2011
Last Update Posted: March 30, 2015