Trial for Microarray Analysis of Colon Cancer Outcome-A (MACCO-A)
Part of paid clinical trials in Deerfield Beach, Florida.
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Study ID
- NCT00127036
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Adenocarcinoma
- Colon Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- XELOX — DRUGXELOX: Oxaliplatin 130 mg/m\^2 intravenously (IV); Capecitabine 825 mg/m\^2 by mouth (po)
- XELIRI — DRUGXELIRI: Irinotecan 240 mg/m\^2 IV; Capecitabine 825 mg/m\^2 by mouth (po)
- Bevacizumab — DRUG7.5 mg/kg intravenously (IV)
Study Details
The purpose of this study is to determine if the investigators can predict the sensitivity or resistance of colon cancer to the two available first line chemotherapy agents.
Key Dates
- First listed
- Aug 5, 2005
- Start date
- Oct 31, 2003
- Status verified
- Dec 2011
- Primary completion
- Dec 31, 2010
- Completion
- Dec 31, 2010
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: XELOX + BevacizumabArm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
- Experimental: XELIRI + BevacizumabArm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
Primary Outcome Measure
Number of Participants Per Treatment Arm, Per Tumor Tissue Response Classifier [ Time Frame: 30 Days After End of Treatment - Average of 6 Months ]
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North Broward Medical Center | Deerfield Beach | Florida | 33064 | - |
| Broward General Medical Center | Fort Lauderdale | Florida | 33316 | - |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | - |
| Center for Cancer Care & Research - Watson Clinic | Lakeland | Florida | 33805 | - |
| Fawcett Memorial Hospital | Port Charlotte | Florida | 33592 | - |
| Martin Memorial | Stuart | Florida | 34994 | - |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | - |
| Bay Area Oncology | Tampa | Florida | 33607 | - |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | - |
| Space Coast Medical Associates | Titusville | Florida | 32796 | - |
| St. Joseph's Candler Health System | Savannah | Georgia | 31405 | - |
| Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68510 | - |
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