Trial of Poor Performance Status Patients (ToPPS)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00892710
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pemetrexed — DRUG
    500 mg/m2 IV given over 10 minutes every 21 days
  • Bevacizumab — DRUG
    15 mg/kg IV every 21 days
  • Carboplatin — DRUG
    AUC=5 IV every 21 days

Study Details

The purpose of this trial is to evaluate three treatment regimens in patients with stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with a performance status of 2 and who were not previously treated.

Key Dates

First listed
May 4, 2009
Start date
Jun 30, 2009
Status verified
May 2015
Primary completion
Jul 31, 2014
Completion
May 31, 2015

Study Design

Enrollment
172 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pemetrexed/Bevacizumab
    * Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days * Bevacizumab 15 mg/kg IV every 21 days
  • Experimental: Pemetrexed/Bevacizumab/Carboplatin
    * Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days * Bevacizumab 15 mg/kg IV every 21 days * Carboplatin AUC=5 IV every 21 days
  • Experimental: Pemetrexed
    Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 18 months ]

Locations (27)

FacilityCityStateZIPSite coordinators
Mayo Clinic - AZScottsdaleArizona85259-
Genesis Cancer CenterHot SpringsArkansas71913-
Northeast Arkansas ClinicJonesboroArkansas72401-
Wilshire Oncology Medical GroupLaVerneCalifornia91750-
Aventura Medical CenterAventuraFlorida33180-
Collaborative Research Group/ Palm Beach Ins of Hem OncBoynton BeachFlorida33435-
Holy Cross HospitalFort LauderdaleFlorida33308-
Florida Cancer SpecialistsFort MyersFlorida33901-
Memorial Regional Cancer CenterHollywoodFlorida33021-
Watson Clinic Center for Cancer Care and ResearchLakelandFlorida33805-
Mount Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
University of ChicagoChicagoIllinois60637-
Northern Indiana Cancer Research ConsortiumSouth BendIndiana46601-
RHHP/ Hope Cancer CenterTerra HauteIndiana47802-
Hematology Oncology Associates of Northern NJMorristownNew Jersey07960-
Oncology Hematology CareCincinnatiOhio45242-
Toledo Community Oncology ProgramToledoOhio43617-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Medical University of South CarolinaCharlestonSouth Carolina29425-
South Carolina Oncology Associates, PAColumbiaSouth Carolina29210-
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Family Cancer CenterMemphisTennessee38120-
Tennessee Oncology, PLLCNashvilleTennessee37023-
The Center for Cancer and Blood DisordersFort WorthTexas76104-
Virginia Cancer InstituteRichmondVirginia23235-

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