Status:
COMPLETED
Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
Lead Sponsor:
Melissa Burgess, MD
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 por...
Detailed Description
Phase 1b * To determine the dose of vorinostat that can be safely combined with gemcitabine and docetaxel in patients with advanced sarcomas. * To characterize the Pharmacokinetics (PK) and Pharmacod...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 24 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01879085
Start Date
September 24 2013
End Date
April 15 2021
Last Update
September 21 2022
Active Locations (1)
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1
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232