FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT01226719
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Panitumumab — DRUG
    6 mg/kg, 60-90 minute IV infusion every 2 weeks
  • Oxaliplatin — DRUG
    85 mg/m2, 2-hour IV infusion every 2 weeks
  • Irinotecan — DRUG
    125 mg/m2, 1-hour IV infusion every 2 weeks
  • Leucovorin — DRUG
    200 mg/m2, 2-hour IV infusion every 2 weeks
  • 5-Fluorouracil — DRUG
    3200 mg/m2 IV, 48-hour continuous infusion every two weeks

Study Details

In this Phase II study the investigators plan to determine the overall response rate (ORR) of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with liver-only metastatic KRAS wild-type colorectal cancer.

Key Dates

Start date
Dec 31, 2010
Status verified
May 2015
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014

Study Design

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

Arms

  • Experimental: FOLFOXIRI+panitumumab regimen
    All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order: * Panitumumab * Oxaliplatin * Irinotecan * Leucovorin * 5-Fluorouracil

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 18 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
NEA Baptist ClinicJonesboroArkansas72401-
Florida Cancer SpecialistsFort MyersFlorida33916-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Hope Cancer CenterTerre HauteIndiana47802-
Providence Medical GroupTerre HauteIndiana47802-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
Portsmouth Regional HospitalPortsmouthNew Hampshire03801-
Hematology-Oncology Associates of Northern NJMorristownNew Jersey07960-
Oncology Hematology Care, IncCincinnatiOhio45242-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Family Cancer CenterColliervilleTennessee38017-
Tennessee Oncology, PLLCNashvilleTennessee37203-
The Center for Cancer and Blood DisordersFort WorthTexas76104-

Find similar trials in Jonesboro, AR

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
NEA Baptist Clinic· Jonesboro, ARFlorida Cancer Specialists· Fort Myers, FLFlorida Hospital Cancer Institute· Orlando, FLFlorida Cancer Specialists· St. Petersburg, FLNortheast Georgia Medical Center· Gainesville, GAHope Cancer Center· Terre Haute, IN

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