Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Part of paid clinical trials in Burbank, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01199263
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

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Paclitaxel — DRUG
    Given IV
  • Pelareorep — BIOLOGICAL
    Given IV

Study Details

This randomized phase II trial studies the side effects and how well giving paclitaxel with or without viral therapy works in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them spreading. Viral therapy may be able to kill tumor cells without damaging normal cells. Giving paclitaxel together with viral therapy may kill more tumor cells.

Key Dates

Start date
Dec 6, 2010
Status verified
Aug 2020
Primary completion
Jun 1, 2015
Completion
Jul 17, 2020

Study Design

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

Arms

  • Experimental: Arm I (paclitaxel)
    Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.
  • Experimental: Arm II (paclitaxel and wild-type reovirus)
    Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Approximately 4.5 years. ]

Locations (36)

FacilityCityStateZIPSite coordinators
Providence Saint Joseph Medical Center/Disney Family Cancer CenterBurbankCalifornia91505-
Palo Alto Medical Foundation-Gynecologic OncologyMountain ViewCalifornia94040-
Smilow Cancer Hospital Care Center at Saint FrancisHartfordConnecticut06105-
Northeast Georgia Medical Center-GainesvilleGainesvilleGeorgia30501-
Saint Alphonsus Cancer Care Center-BoiseBoiseIdaho83706-
Indiana University/Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Michigan Cancer Research Consortium NCORPAnn ArborMichigan48106-
Saint Joseph Mercy HospitalAnn ArborMichigan48106-
Beaumont Hospital - DearbornDearbornMichigan48124-
Ascension Saint John HospitalDetroitMichigan48236-
Hurley Medical CenterFlintMichigan48503-
Genesys Regional Medical CenterGrand BlancMichigan48439-
Allegiance HealthJacksonMichigan49201-
Sparrow HospitalLansingMichigan48912-
Saint Mary Mercy HospitalLivoniaMichigan48154-
Saint Joseph Mercy OaklandPontiacMichigan48341-
Lake Huron Medical CenterPort HuronMichigan48060-
Ascension Saint Mary's HospitalSaginawMichigan48601-
Saint John Macomb-Oakland HospitalWarrenMichigan48093-
Mayo Clinic in RochesterRochesterMinnesota55905-
University of Mississippi Medical CenterJacksonMississippi39216-
Women's Cancer Center of NevadaLas VegasNevada89169-
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87102-
Atrium Health Cabarrus/LCI-ConcordConcordNorth Carolina28025-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic Cancer Center/Fairview HospitalClevelandOhio44111-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Hillcrest Hospital Cancer CenterMayfield HeightsOhio44124-
UH Seidman Cancer Center at Lake Health Mentor CampusMentorOhio44060-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Women and Infants HospitalProvidenceRhode Island02905-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-
Carilion Clinic Gynecological OncologyRoanokeVirginia24016-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Burbank, CA

By research site
Providence Saint Joseph Medical Center/Disney Family Cancer Center· Burbank, CAPalo Alto Medical Foundation-Gynecologic Oncology· Mountain View, CASmilow Cancer Hospital Care Center at Saint Francis· Hartford, CTNortheast Georgia Medical Center-Gainesville· Gainesville, GASaint Alphonsus Cancer Care Center-Boise· Boise, IDIndiana University/Melvin and Bren Simon Cancer Center· Indianapolis, IN

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