Trial Outcomes & Findings for Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer (NCT NCT00449163)
NCT ID: NCT00449163
Last Updated: 2017-05-11
Results Overview
Percentage of patients with overall survival times of up to 2 years
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
2 years
Results posted on
2017-05-11
Participant Flow
A total of 25 subjects were enrolled however; data were analyzed for only 22 of the subjects enrolled.
Participant milestones
| Measure |
Combination Chemotherapy and Bevacizumab
Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
* Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
* Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29;
* Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29;
* Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Combination Chemotherapy and Bevacizumab
Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
* Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
* Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29;
* Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29;
* Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Combination Chemotherapy and Bevacizumab
n=22 Participants
Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
* Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
* Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29;
* Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29;
* Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPercentage of patients with overall survival times of up to 2 years
Outcome measures
| Measure |
Combination Chemotherapy and Bevacizumab
n=22 Participants
Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
* Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
* Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29;
* Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29;
* Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.
|
|---|---|
|
Overall Survival up to 2 Years
|
61 percentage of participants
Interval 27.0 to 83.0
|
SECONDARY outcome
Timeframe: 2 yearsPercentage of patients achieving complete response or partial response per RECIST criteria ver 1.0
Outcome measures
| Measure |
Combination Chemotherapy and Bevacizumab
n=21 Participants
Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
* Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
* Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29;
* Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29;
* Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.
|
|---|---|
|
Response Rate (Complete Response and Partial Response)
|
67 percentage of participants
Interval 43.0 to 85.0
|
SECONDARY outcome
Timeframe: 2 yearsMedian number of months subjects achieved progression-free survival
Outcome measures
| Measure |
Combination Chemotherapy and Bevacizumab
n=21 Participants
Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
* Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
* Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29;
* Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29;
* Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.
|
|---|---|
|
Median Progression-free Survival in Months
|
13 months
Interval 8.4 to 15.0
|
SECONDARY outcome
Timeframe: 2 yearsEvaluation the safety and toxicities of protocol regimen as evidenced by the rate of serious adverse events in study participants.
Outcome measures
| Measure |
Combination Chemotherapy and Bevacizumab
n=22 Participants
Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
* Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
* Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29;
* Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29;
* Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.
|
|---|---|
|
Rate of Toxicity in Study Participants
|
50 percentage of participants
|
Adverse Events
Combination Chemotherapy and Bevacizumab
Serious events: 11 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Combination Chemotherapy and Bevacizumab
n=22 participants at risk
Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
* Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22;
* Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29;
* Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29;
* Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolus
|
4.5%
1/22
Only serious adverse events (Grade 3 and 4) reported.
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
3/22
Only serious adverse events (Grade 3 and 4) reported.
|
|
General disorders
Fatigue
|
9.1%
2/22
Only serious adverse events (Grade 3 and 4) reported.
|
|
Surgical and medical procedures
Port Site Thrombosis
|
9.1%
2/22
Only serious adverse events (Grade 3 and 4) reported.
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
9.1%
2/22
Only serious adverse events (Grade 3 and 4) reported.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
4.5%
1/22
Only serious adverse events (Grade 3 and 4) reported.
|
|
Vascular disorders
DVT
|
13.6%
3/22
Only serious adverse events (Grade 3 and 4) reported.
|
|
Infections and infestations
Infection
|
4.5%
1/22
Only serious adverse events (Grade 3 and 4) reported.
|
Other adverse events
Adverse event data not reported
Additional Information
Bach Ardalan MD
UM/Sylvester Comprehensive Cancer Center
Phone: 305-243-4909
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place