Vorinostat and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00243100
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

  • vorinostat — DRUG
    Given orally
  • gemcitabine hydrochloride — DRUG
    Given IV

Study Details

This phase I trial is studying the side effects and best dose of vorinostat and gemcitabine in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as vorinostat and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Key Dates

Start date
Nov 30, 2005
Status verified
Dec 2013
Primary completion
Aug 31, 2011

Study Design

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

Arms

  • Experimental: Arm I
    Patients receive oral vorinostat (SAHA) once daily on days 1-14 and gemcitabine IV over 1-2 hours on days 3 and 10. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SAHA and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD

Primary Outcome Measure

Maximally tolerated dose of a combination of SAHA and gemcitabine determined by dose-limiting toxicity as measured by NCI CTCAE v3.0 continuously [ Time Frame: 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

Related Studies