Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Part of paid clinical trials in Mobile, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01716715
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

  • Cabozantinib S-malate — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Paclitaxel — DRUG
    Given IV

Study Details

This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.

Key Dates

Start date
Nov 6, 2012
Status verified
Feb 2020
Primary completion
Mar 16, 2015
Completion
Feb 9, 2019

Study Design

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

Arms

  • Experimental: Arm I (cabozantinib-s-malate)
    Patients receive cabozantinib-s-malate PO QD on days 1-28.
  • Experimental: Arm II (paclitaxel)
    Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.

Primary Outcome Measure

Event Free Survival [ Time Frame: The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks ]

Locations (173)

FacilityCityStateZIPSite coordinators
University of South Alabama Mitchell Cancer InstituteMobileAlabama36688-
Providence Saint Joseph Medical Center/Disney Family Cancer CenterBurbankCalifornia91505-
John Muir Medical Center-Concord CampusConcordCalifornia94520-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Los Angeles County-USC Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Gynecologic Oncology Associates-Newport BeachNewport BeachCalifornia92663-
University of Colorado HospitalAuroraColorado80045-
Hartford HospitalHartfordConnecticut06102-
The Hospital of Central ConnecticutNew BritainConnecticut06050-
Beebe Medical CenterLewesDelaware19958-
Christiana Care Health System-Christiana HospitalNewarkDelaware19718-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Sarasota Memorial HospitalSarasotaFlorida34239-
Northeast Georgia Medical Center-GainesvilleGainesvilleGeorgia30501-
Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerSavannahGeorgia31405-
University of Hawaii Cancer CenterHonoluluHawaii96813-
Northwestern UniversityChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Decatur Memorial HospitalDecaturIllinois62526-
Sudarshan K Sharma MD Limited-Gynecologic OncologyHinsdaleIllinois60521-
Good Samaritan Regional Health CenterMount VernonIllinois62864-
Indiana University/Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Saint Vincent Hospital and Health Care CenterIndianapolisIndiana46260-
Mary Greeley Medical CenterAmesIowa50010-
McFarland Clinic PC - AmesAmesIowa50010-
McFarland Clinic PC-BooneBooneIowa50036-
Mercy Cancer Center-West LakesCliveIowa50325-
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-
McFarland Clinic PC-JeffersonJeffersonIowa50129-
McFarland Clinic PC-MarshalltownMarshalltownIowa50158-
Mercy Medical Center-West LakesWest Des MoinesIowa50266-
Cancer Center of Kansas - ChanuteChanuteKansas66720-
Cancer Center of Kansas - Dodge CityDodge CityKansas67801-
Cancer Center of Kansas - El DoradoEl DoradoKansas67042-
Cancer Center of Kansas - Fort ScottFort ScottKansas66701-
Cancer Center of Kansas-IndependenceIndependenceKansas67301-
Cancer Center of Kansas-KingmanKingmanKansas67068-
Lawrence Memorial HospitalLawrenceKansas66044-
Cancer Center of Kansas-LiberalLiberalKansas67905-
Cancer Center of Kansas-ManhattanManhattanKansas66502-
Cancer Center of Kansas - McPhersonMcPhersonKansas67460-
Cancer Center of Kansas - NewtonNewtonKansas67114-
Cancer Center of Kansas - ParsonsParsonsKansas67357-
Cancer Center of Kansas - PrattPrattKansas67124-
Cancer Center of Kansas - SalinaSalinaKansas67401-
Cancer Center of Kansas - WellingtonWellingtonKansas67152-
Associates In Womens HealthWichitaKansas67208-
Cancer Center of Kansas - WichitaWichitaKansas67214-
Cancer Center of Kansas-Wichita Medical Arts TowerWichitaKansas67208-
Via Christi Regional Medical CenterWichitaKansas67214-
Wichita NCI Community Oncology Research ProgramWichitaKansas67214-
Cancer Center of Kansas - WinfieldWinfieldKansas67156-
Woman's HospitalBaton RougeLouisiana70817-
Maine Medical Center-Bramhall CampusPortlandMaine04102-
Maine Medical Center- Scarborough CampusScarboroughMaine04074-
Union Hospital of Cecil CountyElktonMaryland21921-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Baystate Medical CenterSpringfieldMassachusetts01199-
University of Massachusetts Memorial Health CareWorcesterMassachusetts01605-
Borgess Medical CenterKalamazooMichigan49048-
Bronson Methodist HospitalKalamazooMichigan49007-
West Michigan Cancer CenterKalamazooMichigan49007-
Sanford Joe Lueken Cancer CenterBemidjiMinnesota56601-
Saint Dominic-Jackson Memorial HospitalJacksonMississippi39216-
University of Mississippi Medical CenterJacksonMississippi39216-
Saint Francis Medical CenterCape GirardeauMissouri63703-
Freeman Health SystemJoplinMissouri64804-
Cancer Research for the Ozarks NCORPSpringfieldMissouri65804-
CoxHealth South HospitalSpringfieldMissouri65807-
Mercy Hospital SpringfieldSpringfieldMissouri65804-
Mercy Hospital Saint LouisSt LouisMissouri63141-
Washington University School of MedicineSt LouisMissouri63110-
Nebraska Methodist HospitalOmahaNebraska68114-
Women's Cancer Center of NevadaLas VegasNevada89169-
Dartmouth Hitchcock Medical CenterLebanonNew Hampshire03756-
Cooper Hospital University Medical CenterCamdenNew Jersey08103-
NYU Winthrop HospitalMineolaNew York11501-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Stony Brook University Medical CenterStony BrookNew York11794-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Carolinas Medical Center/Levine Cancer InstituteCharlotteNorth Carolina28203-
New Hanover Regional Medical Center/Zimmer Cancer CenterWilmingtonNorth Carolina28401-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Sanford Bismarck Medical CenterBismarckNorth Dakota58501-
Sanford Clinic North-FargoFargoNorth Dakota58122-
Sanford Roger Maris Cancer CenterFargoNorth Dakota58122-
Summa Akron City Hospital/Cooper Cancer CenterAkronOhio44304-
Strecker Cancer Center-BelpreBelpreOhio45714-
Adena Regional Medical CenterChillicotheOhio45601-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic Cancer Center/Fairview HospitalClevelandOhio44111-
Cleveland Clinic FoundationClevelandOhio44195-
Columbus NCI Community Oncology Research ProgramColumbusOhio43215-
Columbus Oncology and Hematology Associates IncColumbusOhio43214-
Doctors HospitalColumbusOhio43228-
Grant Medical CenterColumbusOhio43215-
Mount Carmel Health Center WestColumbusOhio43222-
Riverside Methodist HospitalColumbusOhio43214-
The Mark H Zangmeister CenterColumbusOhio43219-
Miami Valley HospitalDaytonOhio45409-
Delaware Health Center-Grady Cancer CenterDelawareOhio43015-
Delaware Radiation OncologyDelawareOhio43015-
Grady Memorial HospitalDelawareOhio43015-
Fairfield Medical CenterLancasterOhio43130-
Lancaster Radiation OncologyLancasterOhio43130-
Marietta Memorial HospitalMariettaOhio45750-
Hillcrest Hospital Cancer CenterMayfield HeightsOhio44124-
UH Seidman Cancer Center at Lake Health Mentor CampusMentorOhio44060-
Knox Community HospitalMount VernonOhio43050-
Licking Memorial HospitalNewarkOhio43055-
Newark Radiation OncologyNewarkOhio43055-
Southern Ohio Medical CenterPortsmouthOhio45662-
Springfield Regional Medical CenterSpringfieldOhio45505-
Saint Ann's HospitalWestervilleOhio43081-
Genesis Healthcare System Cancer Care CenterZanesvilleOhio43701-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Oklahoma Cancer Specialists and Research Institute-TulsaTulsaOklahoma74146-
Abington Memorial HospitalAbingtonPennsylvania19001-
Women and Infants HospitalProvidenceRhode Island02905-
Sanford Cancer Center Oncology ClinicSioux FallsSouth Dakota57104-
Sanford USD Medical Center - Sioux FallsSioux FallsSouth Dakota57117-5134-
The Don and Sybil Harrington Cancer CenterAmarilloTexas79106-
Baylor All Saints Medical Center at Fort WorthFort WorthTexas76104-
Lyndon Baines Johnson General HospitalHoustonTexas77026-1967-
M D Anderson Cancer CenterHoustonTexas77030-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-
Virginia Commonwealth University/Massey Cancer CenterRichmondVirginia23298-
PeaceHealth Medical Group PCBellinghamWashington98226-
Harrison HealthPartners Hematology and Oncology-BremertonBremertonWashington98310-
Harrison Medical CenterBremertonWashington98310-
Providence Regional Cancer PartnershipEverettWashington98201-
Skagit Valley Hospital Regional Cancer Care CenterMount VernonWashington98274-
Harrison HealthPartners Hematology and Oncology-PoulsboPoulsboWashington98370-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
Kaiser Permanente WashingtonSeattleWashington98112-
Northwest HospitalSeattleWashington98133-
Pacific Gynecology SpecialistsSeattleWashington98104-
Seattle Cancer Care AllianceSeattleWashington98109-
Swedish Medical Center-First HillSeattleWashington98122-4307-
University of Washington Medical CenterSeattleWashington98195-
Olympic Medical Cancer Care CenterSequimWashington98384-
Cancer Care Northwest - Spokane SouthSpokaneWashington99202-
Rockwood Cancer Treatment Center-DHEC-DowntownSpokaneWashington99204-
MultiCare Tacoma General HospitalTacomaWashington98405-
Saint Joseph Medical CenterTacomaWashington98405-
Providence Saint Mary Regional Cancer CenterWalla WallaWashington99362-
Wenatchee Valley Hospital and ClinicsWenatcheeWashington98801-
HSHS Sacred Heart HospitalEau ClaireWisconsin54701-
Marshfield Clinic Cancer Center at Sacred HeartEau ClaireWisconsin54701-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-
Marshfield Medical CenterMarshfieldWisconsin54449-
Marshfield Medical Center-MarshfieldMarshfieldWisconsin54449-
Marshfield Clinic-Minocqua CenterMinocquaWisconsin54548-
ProHealth D N Greenwald CenterMukwonagoWisconsin53149-
ProHealth Oconomowoc Memorial HospitalOconomowocWisconsin53066-
Ascension Saint Mary's HospitalRhinelanderWisconsin54501-
Marshfield Medical Center-Rice LakeRice LakeWisconsin54868-
Ascension Saint Michael's HospitalStevens PointWisconsin54481-
Saint Michael's HospitalStevens PointWisconsin54481-
ProHealth Waukesha Memorial HospitalWaukeshaWisconsin53188-
Diagnostic and Treatment CenterWestonWisconsin54476-
Marshfield Clinic - Weston CenterWestonWisconsin54476-
Marshfield Clinic - Wisconsin Rapids CenterWisconsin RapidsWisconsin54494-

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