Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00741988
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ixabepilone — DRUG
    ixabepilone 30 mg/m2
  • Carboplatin — DRUG
    carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
  • Bevacizumab — DRUG
    bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.

Study Details

This is a multicenter, non-randomized, Phase II study of patients with previously untreated NSCLC not amenable to radiotherapy or surgical treatment. The planned enrollment for this trial is 78 patients (including a 10% rate for inevaluable patients). There will be a total of 39 patients in each cohort (Cohorts A and B).

Key Dates

First listed
Aug 27, 2008
Start date
Sep 30, 2008
Status verified
Dec 2021
Primary completion
Sep 30, 2010
Completion
Sep 30, 2012

Study Design

Enrollment
82 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
  • Experimental: Cohort B
    ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.

Primary Outcome Measure

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
Gainsville Hematology Oncology AssociatesGainesvilleFlorida32605-
Providence Medical GroupTerre HauteIndiana47802-
Consultants in Blood Disorders and CancerLouisvilleKentucky40207-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
Grand Rapids Clinical Oncology ProgramGrand RapidsMichigan49503-
Research Medical CenterKansas CityMissouri64132-
Dr. Donald BerdeauxGreat FallsMontana59405-
Oncology Hematology CareCincinnatiOhio45242-
South Carolina Oncology AssociatesColumbiaSouth Carolina29210-
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303-
Tennessee Oncology, PLLCNashvilleTennessee37023-
Peninsula Cancer InstituteNewport NewsVirginia23601-

Find similar trials in Fort Myers, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Florida Cancer Specialists· Fort Myers, FLGainsville Hematology Oncology Associates· Gainesville, FLProvidence Medical Group· Terre Haute, INConsultants in Blood Disorders and Cancer· Louisville, KYCenter for Cancer and Blood Disorders· Bethesda, MDGrand Rapids Clinical Oncology Program· Grand Rapids, MI

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