Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
GOG Foundation
Study ID
NCT00886691
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
  • Everolimus — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Placebo — OTHER
    Given PO

Study Details

This randomized phase II trial studies how well bevacizumab with or without everolimus works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and everolimus may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with or without everolimus in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Key Dates

First listed
Apr 23, 2009
Start date
Dec 27, 2010
Status verified
Jan 2022
Primary completion
Jun 27, 2014
Completion
Mar 23, 2015

Study Design

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

Arms

  • Experimental: Arm I (bevacizumab and everolimus)
    Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and everolimus PO QD on days 1-28.
  • Experimental: Arm II (bevacizumab and placebo)
    Patients receive bevacizumab as in Arm I and placebo PO QD on days 1-28.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Duration of time from start of treatment to time of progression, approximately 4 years and 6 months. ]

Locations (45)

FacilityCityStateZIPSite coordinators
Gynecologic Oncology Group of ArizonaPhoenixArizona85012-
Providence Saint Joseph Medical Center/Disney Family Cancer CenterBurbankCalifornia91505-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
University of Colorado HospitalAuroraColorado80045-
The Hospital of Central ConnecticutNew BritainConnecticut06050-
Rush University Medical CenterChicagoIllinois60612-
Sudarshan K Sharma MD Limited-Gynecologic OncologyHinsdaleIllinois60521-
Carle Cancer CenterUrbanaIllinois61801-
Indiana University/Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Saint Vincent Hospital and Health Care CenterIndianapolisIndiana46260-
McFarland Clinic PC - AmesAmesIowa50010-
Iowa Lutheran HospitalDes MoinesIowa50316-
Iowa Methodist Medical CenterDes MoinesIowa50309-
Iowa-Wide Oncology Research Coalition NCORPDes MoinesIowa50309-
Medical Oncology and Hematology Associates-Des MoinesDes MoinesIowa50309-
Medical Oncology and Hematology Associates-LaurelDes MoinesIowa50314-
Mercy Medical Center - Des MoinesDes MoinesIowa50314-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Baystate Medical CenterSpringfieldMassachusetts01199-
Saint Joseph Mercy HospitalAnn ArborMichigan48106-
CoxHealth South HospitalSpringfieldMissouri65807-
Mercy Hospital SpringfieldSpringfieldMissouri65804-
Nebraska Methodist HospitalOmahaNebraska68114-
Cooper Hospital University Medical CenterCamdenNew Jersey08103-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203-
Duke University Medical CenterDurhamNorth Carolina27710-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic Cancer Center/Fairview HospitalClevelandOhio44111-
Cleveland Clinic FoundationClevelandOhio44195-
MetroHealth Medical CenterClevelandOhio44109-
Riverside Methodist HospitalColumbusOhio43214-
Hillcrest Hospital Cancer CenterMayfield HeightsOhio44124-
UH Seidman Cancer Center at Lake Health Mentor CampusMentorOhio44060-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Oklahoma Cancer Specialists and Research Institute-TulsaTulsaOklahoma74146-
Jefferson Abington HospitalAbingtonPennsylvania19001-
University of Pennsylvania/Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Reading HospitalWest ReadingPennsylvania19611-
Women and Infants HospitalProvidenceRhode Island02905-
AnMed Health Cancer CenterAndersonSouth Carolina29621-
Baylor All Saints Medical Center at Fort WorthFort WorthTexas76104-
LDS HospitalSalt Lake CityUtah84143-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Phoenix, AZ

By research site
Gynecologic Oncology Group of Arizona· Phoenix, AZProvidence Saint Joseph Medical Center/Disney Family Cancer Center· Burbank, CACedars Sinai Medical Center· Los Angeles, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAUniversity of Colorado Hospital· Aurora, COThe Hospital of Central Connecticut· New Britain, CT

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