Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Melissa Burgess, MD
Study ID
NCT01879085
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Sarcoma

Eligibility Criteria

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

Interventions

  • Docetaxel — DRUG
    75 mg/m2 IV given over 60 minutes on day 8 every 21 days (1 cycle)
  • Gemcitabine — DRUG
    given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, given over 67.5 minutes at 10 mg/m2/min
  • Vorinostat — DRUG
    given orally at the specified dose levels (either 300 mg/daily or 200 mg twice per day) on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle)
  • Pegfilgrastim — DRUG
    administered on day 9 subcutaneously at 6 mg

Study Details

This is a Phase Ib/II experimental, open-label, dose escalation, active treatment study designed to determine the safety, tolerability, and recommended dose of the combination. During the Phase 2 portion of the study, we will assess progression-free survival (PFS), overall survival (OS),overall response rate (ORR), correlative endpoints, DNA methylation measured by microarray, and expression level of the genes as measured by microarray

Key Dates

Start date
Sep 24, 2013
Status verified
Aug 2022
Primary completion
Apr 15, 2021
Completion
Apr 15, 2021

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination therapy
    Dose Level\\Docetaxel IV\\ Gemcitabine IV\\Vorinostat PO\\Pegfilgrastim 1\\75 mg/m2\\900 mg/m2\\300 mg once daily\\6 mg on day 9 2\\75 mg/m2\\900 mg/m2\\200 mg twice daily\\6 mg on day 9 3\\75 mg/m2\\900 mg/m2\\300 mg twice daily\\6 mg on day 9 4\\75 mg/m2\\900 mg/m2\\400 mg twice daily\\6 mg on day 9

Primary Outcome Measure

Phase I: Recommended Phase II Dose of Vorinostat [ Time Frame: During Cycle 1 of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hillman Cancer CenterPittsburghPennsylvania15232-

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By research site
Hillman Cancer Center· Pittsburgh, PA

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