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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XELOX — DRUG
    XELOX: Oxaliplatin 130 mg/m\^2 intravenously (IV); Capecitabine 825 mg/m\^2 by mouth (po)
  • XELIRI — DRUG
    XELIRI: Irinotecan 240 mg/m\^2 IV; Capecitabine 825 mg/m\^2 by mouth (po)
  • Bevacizumab — DRUG
    7.5 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 + Bevacizumab
    Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
  • Experimental: 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

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)

FacilityCityStateZIPSite coordinators
North Broward Medical CenterDeerfield BeachFlorida33064-
Broward General Medical CenterFort LauderdaleFlorida33316-
Florida Cancer SpecialistsFort MyersFlorida33916-
Center for Cancer Care & Research - Watson ClinicLakelandFlorida33805-
Fawcett Memorial HospitalPort CharlotteFlorida33592-
Martin MemorialStuartFlorida34994-
Tallahassee Memorial HospitalTallahasseeFlorida32308-
Bay Area OncologyTampaFlorida33607-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
Space Coast Medical AssociatesTitusvilleFlorida32796-
St. Joseph's Candler Health SystemSavannahGeorgia31405-
Southeast Nebraska Cancer CenterLincolnNebraska68510-

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