Pegylated Liposomal Doxorubicin Hydrochloride, Carboplatin, Veliparib, and Bevacizumab in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01459380
Phase
PHASE1
Status
Completed

Conditions

  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Seromucinous Carcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Undifferentiated Ovarian Carcinoma

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Carboplatin — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
    Given IV
  • Veliparib — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and the best dose of veliparib when given together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab in treating patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has returned after previous treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and carboplatin, may stop the growth of tumor cells by, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth by blocking the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumors by blocking the growth of new blood vessels necessary for tumor growth. Giving veliparib together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab may kill more tumor cells.

Key Dates

First listed
Oct 25, 2011
Start date
Oct 11, 2011
Status verified
Jul 2019
Primary completion
Jun 8, 2016
Completion
Feb 11, 2017

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen I (intermittent veliparib)
    Patients receive veliparib PO BID on days 1-7, and pegylated liposomal doxorubicin hydrochloride IV over 1 hour and carboplatin IV over 30 minutes on day 1.
  • Experimental: Regimen II (continuous veliparib)
    Patients receive veliparib PO BID on days 1-28, and pegylated liposomal doxorubicin hydrochloride and carboplatin as in Regimen I.

Primary Outcome Measure

DLT assessed by NCI CTCAE version 4 [ Time Frame: 16 weeks (first 4 courses) ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer Center - Anschutz Cancer PavilionAuroraColorado80045-
Augusta University Medical CenterAugustaGeorgia30912-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Hillcrest Hospital Cancer CenterMayfield HeightsOhio44124-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Women and Infants HospitalProvidenceRhode Island02905-
Froedtert and the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Aurora, CO

By research site
University of Colorado Cancer Center - Anschutz Cancer Pavilion· Aurora, COAugusta University Medical Center· Augusta, GAUniversity of Chicago Comprehensive Cancer Center· Chicago, ILUniversity of Iowa/Holden Comprehensive Cancer Center· Iowa City, IAJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDMemorial Sloan-Kettering Cancer Center· New York, NY

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