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

Exclusion Criteria

• •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