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

Completed · Phase 1/Phase 2

Conditions studied: Sarcoma

In brief

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 facts

Study ID

NCT01879085

Run by

Melissa Burgess, MD

People needed

37

Starts

2013-09-24

Expected to finish

2021-04-15

Last updated by the study team

2022-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically confirmed soft tissue sarcoma with evidence of metastatic or unresectable disease.
• Patients must have measurable disease by RECIST 1.1.
• Up to 32 prior cytotoxic chemotherapy regimens in the metastatic setting are allowed. Adjuvant chemotherapy or targeted therapy will not be considered a prior line of treatment.
• Age ≥18 years.
• ECOG performance status ≤2 (Karnofsky ≥60%).
• Life expectancy of greater than 12 weeks.
• Patients must have normal organ and marrow function as defined below:
• leukocytes ≥3,000/µL
• absolute neutrophil count ≥1,500/µL
• platelets ≥100,000/µL
• total bilirubin within normal institutional limits
• AST(SGOT)/ALT(SGPT) ≤1.5 X institutional upper limit of normal (ULN)
• creatinine ≤1.5 X institutional upper limit of normal (ULN)
• Peripheral neuropathy, if present, should be ≤grade 1.
• Women of Child bearing potential MUST use contraceptives.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• The following specific histologic subtypes of soft tissue sarcomas will be excluded: GIST, Kaposi's sarcoma, mesothelioma, dermatofibrosarcoma, chordoma, alveolar soft-part sarcoma. Also, all bone sarcomas are excluded including Ewing's sarcoma, osteosarcoma, GIST, low grade chondrosarcoma, and chordoma.
• Patients who have had treatment with chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients who are receiving any other investigational agents.
• Patients with known brain metastases.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, docetaxel, vorinostat, or G-CSF.
• Patients who have received and progressed on the combination of gemcitabine and docetaxel in the metastatic setting.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant and breastfeeding women
• Patients taking concomitant HDAC inhibitors.
• HIV-positive patients on combination antiretroviral treatment

Where it is running

• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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