Vorinostat and Doxorubicin in Treating Patients With Metastatic or Locally Advanced Solid Tumors

Part of paid clinical trials in Tampa, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00331955
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

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

Study Details

This phase I trial is studying the side effects and best dose of vorinostat when given together with doxorubicin in treating patients with metastatic or locally advanced solid tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may help doxorubicin work better by making tumor cells more sensitive to the drug.

Key Dates

Start date
Mar 31, 2006
Status verified
Jul 2013
Primary completion
Jun 30, 2012

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (vorinostat, doxorubicin hydrochloride)
    Patients receive oral vorinostat twice daily for 5 doses on days 1-3, 8-10, and 15-17 and doxorubicin hydrochloride IV on days 3, 10, and 17. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 6 courses of treatment may continue to receive vorinostat alone in the absence of disease progression.

Primary Outcome Measure

Safety and tolerability as assessed by NCI CTCAE v3.0 [ Time Frame: Up to 30 days after completion of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

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By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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