Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT01084057
Phase
PHASE1
Status
Completed

Conditions

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer

Eligibility Criteria

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

Interventions

  • vorinostat — DRUG
    Given orally
  • ixabepilone — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing or by stopping them from spreading. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ixabepilone together with vorinostat may kill more tumor cells. PURPOSE: This randomized phase I trial is studying the side effects, best way to give, and best dose of vorinostat when given together with ixabepilone in treating patients with breast cancer that has spread to another place in the body.

Key Dates

Start date
May 17, 2010
Status verified
Oct 2019
Primary completion
Nov 12, 2012
Completion
Sep 27, 2019

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (Cohort A)
    Patients receive oral vorinostat once daily on days 1-14 and ixabepilone IV over 3 hours on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (Cohort B)
    Patients receive oral vorinostat once daily on days 1-7 and 15-21. Patients also receive ixabepilone IV over 3 hours on days 2, 9, and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Dose limiting toxicity defined as any treatment-related grade 3 or greater non-hematologic toxicity, grade 4 febrile neutropenia, thrombocytopenia or grade 4 neutropenia as a result of unresolved toxicity [ Time Frame: Cohort A evaluated every 3 weeks during treatment, Cohort B every 4 weeks during treatment. ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
South Pasadena Cancer CenterSouth PasadenaCalifornia91030-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CASouth Pasadena Cancer Center· South Pasadena, CA

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