Bevacizumab With or Without Fosbretabulin Tromethamine in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01305213
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Fosbretabulin Tromethamine — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This randomized phase II trial studies how well bevacizumab with or without fosbretabulin tromethamine works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer that has come back or is persistent. Monoclonal antibodies, such as bevacizumab, find tumor cells and help kill them. Bevacizumab and fosbretabulin tromethamine may stop the growth of ovarian cancer by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective with or without fosbretabulin tromethamine in treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.

Key Dates

First listed
Feb 28, 2011
Start date
Mar 21, 2011
Status verified
Jul 2019
Primary completion
Aug 20, 2016
Completion
Nov 3, 2016

Study Design

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

Arms

  • Active Comparator: Arm I (bevacizumab)
    Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (bevacizumab, fosbretabulin tromethamine)
    Patients receive bevacizumab IV over 30-90 minutes and fosbretabulin tromethamine IV over 10-20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21 day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, up to 5 years ]

Locations (51)

FacilityCityStateZIPSite coordinators
Saint Joseph's Hospital and Medical CenterPhoenixArizona85013-
Providence Saint Joseph Medical Center/Disney Family Cancer CenterBurbankCalifornia91505-
John Muir Medical Center-Concord CampusConcordCalifornia94520-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Sutter Medical Center SacramentoSacramentoCalifornia95816-
Penrose-Saint Francis HealthcareColorado SpringsColorado80907-
Presbyterian - Saint Lukes Medical Center - Health OneDenverColorado80218-
SCL Health Lutheran Medical CenterWheat RidgeColorado80033-
Hartford HospitalHartfordConnecticut06102-
Beebe Medical CenterLewesDelaware19958-
Christiana Care Health System-Christiana HospitalNewarkDelaware19718-
Mercy HospitalMiamiFlorida33133-
Northeast Georgia Medical Center-GainesvilleGainesvilleGeorgia30501-
Memorial Health University Medical CenterSavannahGeorgia31404-
Saint Alphonsus Cancer Care Center-BoiseBoiseIdaho83706-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Sudarshan K Sharma MD Limited-Gynecologic OncologyHinsdaleIllinois60521-
Indiana University/Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Saint Vincent Hospital and Health Care CenterIndianapolisIndiana46260-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Maine Medical Center-Bramhall CampusPortlandMaine04102-
MedStar Franklin Square Medical Center/Weinberg Cancer InstituteBaltimoreMaryland21237-
Sinai Hospital of BaltimoreBaltimoreMaryland21215-
University of Massachusetts Memorial Health CareWorcesterMassachusetts01605-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Borgess Medical CenterKalamazooMichigan49048-
Bronson Methodist HospitalKalamazooMichigan49007-
West Michigan Cancer CenterKalamazooMichigan49007-
Saint Dominic-Jackson Memorial HospitalJacksonMississippi39216-
University of Mississippi Medical CenterJacksonMississippi39216-
Washington University School of MedicineSt LouisMissouri63110-
Women's Cancer Center of NevadaLas VegasNevada89169-
Novant Health Presbyterian Medical CenterCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
Summa Akron City Hospital/Cooper Cancer CenterAkronOhio44304-
University of Cincinnati/Barrett Cancer CenterCincinnatiOhio45219-
Cleveland Clinic Cancer Center/Fairview HospitalClevelandOhio44111-
Hillcrest Hospital Cancer CenterMayfield HeightsOhio44124-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Women and Infants HospitalProvidenceRhode Island02905-
Greenville Health System Cancer Institute-EastsideGreenvilleSouth Carolina29615-
Sanford Cancer Center Oncology ClinicSioux FallsSouth Dakota57104-
Sanford USD Medical Center - Sioux FallsSioux FallsSouth Dakota57117-5134-
Virginia Commonwealth University/Massey Cancer CenterRichmondVirginia23298-
Green Bay Oncology at Saint Vincent HospitalGreen BayWisconsin54301-3526-
Green Bay Oncology Limited at Saint Mary's HospitalGreen BayWisconsin54303-
Saint Vincent Hospital Cancer Center Green BayGreen BayWisconsin54301-
Holy Family Memorial HospitalManitowocWisconsin54221-
Bay Area Medical CenterMarinetteWisconsin54143-

Find similar trials in Phoenix, AZ

By research site
Saint Joseph's Hospital and Medical Center· Phoenix, AZProvidence Saint Joseph Medical Center/Disney Family Cancer Center· Burbank, CAJohn Muir Medical Center-Concord Campus· Concord, CAUC San Diego Moores Cancer Center· La Jolla, CACedars Sinai Medical Center· Los Angeles, CASutter Medical Center Sacramento· Sacramento, CA

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