High-Dose or Low-Dose Vorinostat in Combination With Carboplatin or Paclitaxel in Treating Patients With Advanced Solid Tumors

Conditions

• Adult Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Paclitaxel — DRUG
  Given IV
• Pharmacological Study — OTHER
  Correlative studies
• Vorinostat — DRUG
  Given PO

Study Details

This randomized pilot clinical trial studies high-dose or low-dose vorinostat in combination with carboplatin or paclitaxel in treating patients with 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 carboplatin and 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 from spreading. Giving different doses of vorinostat together with carboplatin or paclitaxel may kill more tumor cells.

Key Dates

Start date

Feb 9, 2011

Status verified

Apr 2026

Primary completion

Apr 30, 2014

Completion

Apr 17, 2027

Study Design

Enrollment

20 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (high- and low-dose vorinostat and carboplatin)
  Patients receive high-dose vorinostat PO QD on days 1-3 and low-dose vorinostat PO QD on days 8-10 (course 0). After 5 days, patients receive high-dose vorinostat PO QD on days 1-3 and carboplatin IV over 30 minutes on day 3 of all subsequent courses.
• Experimental: Arm II (high- and low-dose vorinostat and carboplatin)
  Patients receive high-dose vorinostat and low-dose vorinostat as in Arm I. After 5 days, patients receive lower-dose vorinostat PO QD on days 1-3 and carboplatin IV over 30 minutes on day 3.
• Experimental: Arm III (low- and high-dose vorinostat and carboplatin)
  Patients receive low-dose vorinostat PO QD on days 1-3 and high-dose vorinostat PO QD on days 8-10 (course 0). After 5 days, patients receive vorinostat and carboplatin as in Arm I.
• Experimental: Arm IV (low- and high-dose vorinostat and carboplatin)
  Patients receive low-dose vorinostat and high-dose vorinostat as in Arm III. After 5 days, patients receive vorinostat and carboplatin as in Arm II.
• Experimental: Arm V (low- and mid-dose vorinostat and paclitaxel)
  Patients receive low-dose vorinostat PO QD on days 1-3 and mid-dose vorinostat PO QD on days 8-10 (course 0). After 5 days, patients receive mid-dose vorinostat PO QD on days 1-3 and paclitaxel IV over 3 hours on day 3.
• Experimental: Arm VI (mid- and low-dose vorinostat and paclitaxel)
  Patients receive mid-dose vorinostat PO QD on days 1-3 and low-dose vorinostat PO QD on days 8-10. After 5 days, patients receive vorinostat and paclitaxel as in Arm V.

Primary Outcome Measure

Peak concentrations (Cmax) of vorinostat at 400, 1200, and 1600 mg [ Time Frame: 0 (pre-treatment), 60, 120, 180, 240, 360 and 480 minutes and 24 hours after vorinostat administration on days 3 and 10 of course 0 and on day 3 of course 1 ]

Locations (1)

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