Trial Outcomes & Findings for Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A) (NCT NCT00127036)
NCT ID: NCT00127036
Last Updated: 2017-03-23
Results Overview
Investigators would develop tumor tissue classifiers to predict response to the XELOX arm or XELIRI arm; with gene expression profiles on 75 patients on each of 2 arms, construct 2 classifiers to distinguish responders (complete responses, partial responses, stable disease) from non-responders (progressive disease).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
30 Days After End of Treatment - Average of 6 Months
Results posted on
2017-03-23
Participant Flow
Participant milestones
| Measure |
XELOX + Bevacizumab
Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
|
XELIRI + Bevacizumab
Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
31
|
|
Overall Study
COMPLETED
|
26
|
20
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
XELOX + Bevacizumab
Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
|
XELIRI + Bevacizumab
Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
|
|---|---|---|
|
Overall Study
Insufficient Data for Analysis
|
6
|
11
|
|
Overall Study
Screen Failure
|
2
|
0
|
Baseline Characteristics
Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)
Baseline characteristics by cohort
| Measure |
XELOX + Bevacizumab
n=34 Participants
Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
|
XELIRI + Bevacizumab
n=31 Participants
Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Age, Continuous
|
62.5 years
n=99 Participants
|
64 years
n=107 Participants
|
63 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
31 participants
n=107 Participants
|
65 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 Days After End of Treatment - Average of 6 MonthsPopulation: Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.
Investigators would develop tumor tissue classifiers to predict response to the XELOX arm or XELIRI arm; with gene expression profiles on 75 patients on each of 2 arms, construct 2 classifiers to distinguish responders (complete responses, partial responses, stable disease) from non-responders (progressive disease).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 Days After End of Treatment - Average of 6 MonthsPopulation: Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.
Investigators planned to evaluate the overall survival of colorectal cancer (CRC) patients treated with XELOX + bevacizumab (Arm A) or XELIRI + bevacizumab (Arm B).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 Days After End of Treatment - Average of 6 MonthsPopulation: All participants.
Review of Serious Adverse Events (SAEs) To assess the toxicity associated with Arms A and B. Response rates and toxicity rates for each arm were to be estimated and exact (using Casella's method) 95% confidence intervals for those proportions computed. With the anticipated 75 patients in each arm, these estimated proportions would have standard errors not exceeding 7%.
Outcome measures
| Measure |
XELOX + Bevacizumab
n=34 Participants
Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
|
XELIRI + Bevacizumab
n=31 Participants
Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
9 participants
|
11 participants
|
Adverse Events
XELOX + Bevacizumab
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
XELIRI + Bevacizumab
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
XELOX + Bevacizumab
n=34 participants at risk
Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
|
XELIRI + Bevacizumab
n=31 participants at risk
Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Number of events 1 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Blood and lymphatic system disorders
Bilirubin - hospitalized
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Gastrointestinal disorders
Choking incident while taking tablet
|
2.9%
1/34 • Number of events 1 • 5 years, 5 months
|
0.00%
0/31 • 5 years, 5 months
|
|
Blood and lymphatic system disorders
Coagulation
|
2.9%
1/34 • Number of events 1 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Hepatobiliary disorders
Death due to disease progression - liver
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Gastrointestinal disorders
Dehydration
|
2.9%
1/34 • Number of events 1 • 5 years, 5 months
|
0.00%
0/31 • 5 years, 5 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Gastrointestinal disorders
Diarrhea
|
8.8%
3/34 • Number of events 3 • 5 years, 5 months
|
9.7%
3/31 • Number of events 3 • 5 years, 5 months
|
|
Gastrointestinal disorders
Diarrhea - persistent
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Gastrointestinal disorders
Dyspnea (shortness of breath)
|
2.9%
1/34 • Number of events 1 • 5 years, 5 months
|
0.00%
0/31 • 5 years, 5 months
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)
|
2.9%
1/34 • Number of events 1 • 5 years, 5 months
|
0.00%
0/31 • 5 years, 5 months
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Number of events 2 • 5 years, 5 months
|
12.9%
4/31 • Number of events 4 • 5 years, 5 months
|
|
Gastrointestinal disorders
Obstructing lesion of the colon
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
General disorders
Pain - headache
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Gastrointestinal disorders
Perforation, GI - Duodenum
|
0.00%
0/34 • 5 years, 5 months
|
3.2%
1/31 • Number of events 1 • 5 years, 5 months
|
|
Gastrointestinal disorders
Small bowel obstruction
|
2.9%
1/34 • Number of events 1 • 5 years, 5 months
|
0.00%
0/31 • 5 years, 5 months
|
|
Gastrointestinal disorders
Vomiting
|
14.7%
5/34 • Number of events 5 • 5 years, 5 months
|
9.7%
3/31 • Number of events 3 • 5 years, 5 months
|
Other adverse events
Adverse event data not reported
Additional Information
Jonathan Strosberg, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-2069
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place