Weekly vs. Every 2 Week vs. Every 3 Week Administration of ABI-007 (Abraxane)/Bevacizumab Combination in Metastatic Breast Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Celgene
Study ID
NCT00281528
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • ABI-007 (Abraxane) — DRUG
    30 minute infusions
  • bevacizumab — DRUG
    infusions

Study Details

This is a multi-center, open-label, randomized Phase II study in previously untreated patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense ABI-007 (Abraxane) compared to 2-weekly regimen vs the standard 3-weekly infusion. All patients will also receive concurrent bevacizumab.

Key Dates

First listed
Jan 25, 2006
Start date
Feb 1, 2006
Status verified
Nov 2019
Primary completion
Jul 1, 2010
Completion
Mar 1, 2011

Study Design

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

Arms

  • Experimental: 260 mg/m^2 ABI-007 every 3 weeks
    260 mg/m\^2 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks
  • Experimental: 260 mg/m^2 ABI-007 every 2 weeks
    260 mg/m\^2 ABI-007 every 2 weeks and 10 mg/kg bevacizumab every 2 weeks
  • Experimental: 130 mg/m^2 ABI-007 weekly
    130 mg/m\^2 ABI-007 weekly (without a week of 'rest') and 10 mg/kg bevacizumab every 2 weeks

Primary Outcome Measure

The Percentage of Participants Confirmed Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria In Solid Tumors (RECIST v1.0) [ Time Frame: Up to 43 months ]

Locations (39)

FacilityCityStateZIPSite coordinators
Division of Hematology/Oncology University of Alabama at BirminghamBirminghamAlabama--
Little Rock Hematology Oncology AssociatesLittle RockArkansas--
California Oncology of the Central ValleyFresnoCalifornia--
Glendale Memorial Hospital & Health CenterGlendaleCalifornia--
Front Range Cancer SpecialistsFort CollinsColorado--
Oncology Associates of BridgeportBridgeportConnecticut06610-
Palm Beach Institute of Hematology and OncologyBoynton BeachFlorida--
Memorial Cancer Institute/Breast Cancer CenterHollywoodFlorida33021-
Florida Cancer InstituteHudsonFlorida--
Hematology Oncology AssociatesLake WorthFlorida--
Medical Specialist of the Palm Beaches, IncLake WorthFlorida--
Gulfcoast Oncology AssociatesSt. PetersburgFlorida--
Peachtree Hematology & Oncology AssociatesAtlantaGeorgia--
Northwest Georgia Oncology Centers, PCMariettaGeorgia--
Center of Hope for Cancers and BloodStockbridgeGeorgia30281-
Maine Center for Cancer Medicine & Blood DisordersScarboroughMaine--
Greater Baltimore Medical CenterBaltimoreMaryland--
Harbor View Cancer CenterBaltimoreMaryland--
Boston Medical Center Moakley Building, Solomont Center for Hematology & Medical OncologyBostonMassachusetts--
North Shore Medical Cancer CenterPeabodyMassachusetts01960-
St. John's Mercy Medical CenterSt LouisMissouri--
Nebraska Methodist HospitalOmahaNebraska--
Drs. Forte, Schleidere, & Attas, PAEnglewoodNew Jersey--
Saint Barnabas Medical CenterLivingstonNew Jersey--
Monmouth Medical CenterLong BranchNew Jersey--
Rosewell Park Cancer Institute Elm & Carlton Carlton BuildingBuffaloNew York--
Beth Israel Comprehensive Cancer CenterNew YorkNew York--
Memorial Sloan Kettering Cancer CenterNew YorkNew York--
NYU Clinical Cancer CenterNew YorkNew York--
Marion L. Shepard Cancer CenterWashingtonNorth Carolina--
Medical Oncology Aultman HospitalCantonOhio--
Cancer Centers of Southwest Oklahoma ResearchLawtonOklahoma--
Abington Hematology OncologyWillow GrovePennsylvania--
Family Cancer CenterColliervilleTennessee--
Tennessee Cancer SpecialistsKnoxvilleTennessee--
TX Oncology, PAAustinTexas--
South Texas Oncology & Hematology Clinical Research Dept.San AntonioTexas--
Virginia Commonwealth University Medical OncologyRichmondVirginia--
Swedish Cancer InstituteSeattleWashington--

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Division of Hematology/Oncology University of Alabama at Birmingham· Birmingham, ALLittle Rock Hematology Oncology Associates· Little Rock, ARCalifornia Oncology of the Central Valley· Fresno, CAGlendale Memorial Hospital & Health Center· Glendale, CAFront Range Cancer Specialists· Fort Collins, COOncology Associates of Bridgeport· Bridgeport, CT

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