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Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)

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ClinicalTrials.gov Identifier: NCT00127036
Recruitment Status : Terminated (drug now on market)
First Posted : August 5, 2005
Results First Posted : April 5, 2012
Last Update Posted : March 23, 2017
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma
Colon Cancer
Interventions Drug: XELOX
Drug: XELIRI
Drug: Bevacizumab
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title XELOX + Bevacizumab XELIRI + Bevacizumab
Hide Arm/Group Description Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Period Title: Overall Study
Started 34 31
Completed 26 [1] 20 [2]
Not Completed 8 11
Reason Not Completed
Insufficient Data for Analysis             6             11
Screen Failure             2             0
[1]
26 Participants were evaluable.
[2]
20 Participants were evaluable.
Arm/Group Title XELOX + Bevacizumab XELIRI + Bevacizumab Total
Hide Arm/Group Description Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression Total of all reporting groups
Overall Number of Baseline Participants 34 31 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 31 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  52.9%
18
  58.1%
36
  55.4%
>=65 years
16
  47.1%
13
  41.9%
29
  44.6%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 31 participants 65 participants
62.5
(39 to 88)
64
(38 to 82.5)
63
(38 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 31 participants 65 participants
Female
12
  35.3%
10
  32.3%
22
  33.8%
Male
22
  64.7%
21
  67.7%
43
  66.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 31 participants 65 participants
34 31 65
1.Primary Outcome
Title Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier
Hide Description 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).
Time Frame 30 Days After End of Treatment - Average of 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.
Arm/Group Title XELOX + Bevacizumab XELIRI + Bevacizumab
Hide Arm/Group Description:
Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants Per Treatment Arm, With Overall Survival (OS)
Hide Description Investigators planned to evaluate the overall survival of colorectal cancer (CRC) patients treated with XELOX + bevacizumab (Arm A) or XELIRI + bevacizumab (Arm B).
Time Frame 30 Days After End of Treatment - Average of 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Low accrual and early termination prevented us from performing the planned analysis. Too few patients had both clinical and microarray data.
Arm/Group Title XELOX + Bevacizumab XELIRI + Bevacizumab
Hide Arm/Group Description:
Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description 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%.
Time Frame 30 Days After End of Treatment - Average of 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title XELOX + Bevacizumab XELIRI + Bevacizumab
Hide Arm/Group Description:
Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Overall Number of Participants Analyzed 34 31
Measure Type: Number
Unit of Measure: participants
9 11
Time Frame 5 years, 5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title XELOX + Bevacizumab XELIRI + Bevacizumab
Hide Arm/Group Description Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
All-Cause Mortality
XELOX + Bevacizumab XELIRI + Bevacizumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
XELOX + Bevacizumab XELIRI + Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/34 (26.47%)      11/31 (35.48%)    
Blood and lymphatic system disorders     
Bilirubin - hospitalized  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Coagulation  1  1/34 (2.94%)  1 1/31 (3.23%)  1
Hyperbilirubinemia  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Gastrointestinal disorders     
Abdominal distention  1 [1]  0/34 (0.00%)  0 1/31 (3.23%)  1
Abdominal pain  1 [2]  1/34 (2.94%)  1 1/31 (3.23%)  1
Anorexia  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Choking incident while taking tablet  1  1/34 (2.94%)  1 0/31 (0.00%)  0
Dehydration  1 [3]  1/34 (2.94%)  1 0/31 (0.00%)  0
Diarrhea  1 [4]  3/34 (8.82%)  3 3/31 (9.68%)  3
Diarrhea - persistent  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Dyspnea (shortness of breath)  1  1/34 (2.94%)  1 0/31 (0.00%)  0
Epigastric pain  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Hemorrhage, GI - Rectum  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Nausea  1 [5]  2/34 (5.88%)  2 4/31 (12.90%)  4
Obstructing lesion of the colon  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Perforation, GI - Duodenum  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Small bowel obstruction  1  1/34 (2.94%)  1 0/31 (0.00%)  0
Vomiting  1 [6]  5/34 (14.71%)  5 3/31 (9.68%)  3
General disorders     
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9/L)  1  1/34 (2.94%)  1 0/31 (0.00%)  0
Pain - headache  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Hepatobiliary disorders     
Death due to disease progression - liver  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Nervous system disorders     
CNS cerebrovascular ischemia  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Psychiatric disorders     
Depression  1  0/34 (0.00%)  0 1/31 (3.23%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
[1]
Also experienced pain
[2]
1 on Arm A also experienced vomiting and dehydration
[3]
Also experienced vomiting and abdominal pain
[4]
2 in Arm A and 1 in Arm B also had vomiting. 2 in Arm B also had nausea.
[5]
2 in Arm A and 3 in Arm B also experienced vomiting. 2 in Arm B also experienced diarrhea.
[6]
2 in Arm A and 3 in Arm B also experienced nausea. 1 in Arm B also experienced diarrhea.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
XELOX + Bevacizumab XELIRI + Bevacizumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      0/31 (0.00%)    
Study was Terminated early, not Completed. Study Drug now on the market. Due to slow accrual, too few patients who had both clinical and microarray data to perform the proposed analysis. 65 of 92 patients consented were assigned to treatment arms.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jonathan Strosberg, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-2069
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00127036     History of Changes
Other Study ID Numbers: MCC-13449
R21 CA10135 ( Other Grant/Funding Number: NCI )
XEL390 ( Other Identifier: Roche )
2005-0729 ( Other Identifier: Pfizer )
First Submitted: August 3, 2005
First Posted: August 5, 2005
Results First Submitted: January 5, 2012
Results First Posted: April 5, 2012
Last Update Posted: March 23, 2017