Trial Outcomes & Findings for Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients (NCT NCT00354978)
NCT ID: NCT00354978
Last Updated: 2011-10-21
Results Overview
PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
From baseline until first documented progression or death from any cause, whichever came first, assessed up to 75 months
Results posted on
2011-10-21
Participant Flow
Recruitment Period: January 13, 2005 through January 31, 2007. All recruitment done at UT MD Anderson Cancer Center.
Forty nine (49) patients were enrolled onto the study, and 6 patients did not meet inclusion criteria and were excluded.
Participant milestones
| Measure |
FOLFIRI Plus Bevacizumab
FOLFIRI \[folinic acid (leucovorin) 400 mg/m\^2 by vein (IV) Day 1; 5-FU 400 mg/m\^2 IV injection Day 1 immediately followed by 2.4 g/m\^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m\^2 IV on Day 1\] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients
Baseline characteristics by cohort
| Measure |
FOLFIRI Plus Bevacizumab
n=43 Participants
FOLFIRI \[folinic acid (leucovorin) 400 mg/m\^2 by vein (IV) Day 1; 5-FU 400 mg/m\^2 IV injection Day 1 immediately followed by 2.4 g/m\^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m\^2 IV on Day 1\] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
|
|---|---|
|
Age Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline until first documented progression or death from any cause, whichever came first, assessed up to 75 monthsPopulation: Analysis per protocol.
PFS is defined as the duration of time from start of treatment to time of disease progression using Kaplan-Meier median PFS time.
Outcome measures
| Measure |
FOLFIRI Plus Bevacizumab
n=43 Participants
FOLFIRI \[folinic acid (leucovorin) 400 mg/m\^2 by vein (IV) Day 1; 5-FU 400 mg/m\^2 IV injection Day 1 immediately followed by 2.4 g/m\^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m\^2 IV on Day 1\] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
|
|---|---|
|
Median Progression-free Survival (PFS)
|
12.8 Months
95% Confidence Interval .02 • Interval 9.6 to 15.2
|
Adverse Events
FOLFIRI Plus Bevacizumab
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FOLFIRI Plus Bevacizumab
n=43 participants at risk
FOLFIRI \[folinic acid (leucovorin) 400 mg/m\^2 by vein (IV) Day 1; 5-FU 400 mg/m\^2 IV injection Day 1 immediately followed by 2.4 g/m\^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m\^2 IV on Day 1\] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
|
|---|---|
|
Metabolism and nutrition disorders
ALT,SGPT (Serum Glutamic Pyruvic Transaminase)
|
20.9%
9/43 • 3 years and 4 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.3%
7/43 • 3 years and 4 months
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
16.3%
7/43 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.2%
22/43 • 3 years and 4 months
|
|
Gastrointestinal disorders
Constipation
|
14.0%
6/43 • 3 years and 4 months
|
|
General disorders
Fatigue
|
44.2%
19/43 • 3 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Syndrome
|
11.6%
5/43 • 3 years and 4 months
|
|
General disorders
Headache
|
23.3%
10/43 • 3 years and 4 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
44.2%
19/43 • 3 years and 4 months
|
|
Gastrointestinal disorders
Hemorrhage (Rectum)
|
14.0%
6/43 • 3 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, Pulmonary (Nose)
|
44.2%
19/43 • 3 years and 4 months
|
|
Reproductive system and breast disorders
Hot Flashes
|
23.3%
10/43 • 3 years and 4 months
|
|
Metabolism and nutrition disorders
Hypertension
|
18.6%
8/43 • 3 years and 4 months
|
|
General disorders
Mucositis (Oral Cavity)
|
25.6%
11/43 • 3 years and 4 months
|
|
Gastrointestinal disorders
Nausea
|
44.2%
19/43 • 3 years and 4 months
|
|
General disorders
Neuropathy (Sensory)
|
16.3%
7/43 • 3 years and 4 months
|
|
Metabolism and nutrition disorders
Neutrophils/Granulocytes (ANC/AGC)
|
32.6%
14/43 • 3 years and 4 months
|
|
General disorders
Pain (Muscle)
|
27.9%
12/43 • 3 years and 4 months
|
|
Metabolism and nutrition disorders
Proteinuria
|
25.6%
11/43 • 3 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary (Other)
|
11.6%
5/43 • 3 years and 4 months
|
|
General disorders
Serum Glutamic Oxaloacetic Transaminase (AST)
|
41.9%
18/43 • 3 years and 4 months
|
|
General disorders
Sweating
|
11.6%
5/43 • 3 years and 4 months
|
|
Vascular disorders
Thrombosis (Embolism)
|
11.6%
5/43 • 3 years and 4 months
|
|
Gastrointestinal disorders
Vomiting
|
37.2%
16/43 • 3 years and 4 months
|
|
Eye disorders
Watery Eye
|
27.9%
12/43 • 3 years and 4 months
|
Additional Information
Scott Kopetz, MD Associate Professor
UT MD Anderson Cancer Center
Phone: 713-792-2828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place