A Trial of Single Agent Axitinib as Maintenance Therapy for Patients With First Line Metastatic Colorectal Cancer (mCRC)

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT01490866
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Axitinib — DRUG
    5-mg tablets PO BID
  • Bevacizumab — DRUG
    5 mg/kg Days 1 and 15; IV
  • 5-Fluorouracil — DRUG
    400 mg/m2 Days 1 and 15; IV
  • 5-Fluorouracil — DRUG
    2400 mg/m2 over 46-48 hours Days 1 and 15; Continuous Intravenous
  • Leucovorin — DRUG
    400 mg/m2 Days 1 and 15; IV
  • Oxaliplatin — DRUG
    85 mg/m2 Days 1 and 15; IV

Study Details

This is a non-randomized, open-label, Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC.

Key Dates

First listed
Dec 13, 2011
Start date
Jan 31, 2012
Status verified
Sep 2019
Primary completion
Jul 31, 2015
Completion
Jul 31, 2015

Study Design

Enrollment
70 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFOX/bevacizumab and Axitinib
    Phase II trial investigating axitinib as a single-agent maintenance therapy following standard first-line FOLFOX/bevacizumab therapy for patients with mCRC. (FOLFOX is a combination of 5-Fluorouracil, Leucovorin and Oxaliplatin.) All patients will receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, maintenance axitinib will be started.

Primary Outcome Measure

Progression-free Survival [ Time Frame: 24 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
NEA Baptist ClinicJonesboroArkansas72401-
Florida Cancer Specialists-SouthFort MyersFlorida33916-
Woodlands Medical SpecialistsPensacolaFlorida32503-
Florida Cancer Specialists-NorthSt. PetersburgFlorida33705-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Oncology Hematology of SW IndianaNewburghIndiana47630-
Hope Cancer CenterTerre HauteIndiana47802-
Grand Rapids Oncology ProgramGrand RapidsMichigan49503-
Nebraska Methodist HospitalOmahaNebraska68114-
Atlantic Health SystemSummitNew Jersey07901-
Tennessee OncologyNashvilleTennessee37203-
Texas Health Physician GroupDallasTexas75243-

Find similar trials in Jonesboro, AR

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
NEA Baptist Clinic· Jonesboro, ARFlorida Cancer Specialists-South· Fort Myers, FLWoodlands Medical Specialists· Pensacola, FLFlorida Cancer Specialists-North· St. Petersburg, FLNortheast Georgia Medical Center· Gainesville, GAOncology Hematology of SW Indiana· Newburgh, IN

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