Clinical trial · Interventional
Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
Phase 1b/2 Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
NCT01879085CI-TRIAL-00060950GemTaxcompletedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
| Vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination therapy
- description
- 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
- interventionNames
- Drug: Docetaxel
- Drug: Gemcitabine
- Drug: Vorinostat
- Drug: Pegfilgrastim
Primary outcomes (2)
- measure
- Phase I: Recommended Phase II Dose of Vorinostat
- timeFrame
- During Cycle 1 of treatment
- description
- Recommended Phase ll dose of vorinostat that can be safely combined with gemcitabine and docetaxel. Gemcitabine and docetaxel were given at a fixed dose while vorinostat was dose-escalated using a standard '3+3' design. Dose-limiting toxicity (DLT) is defined as specific study drug-related events experienced during Cycle 1; only DLTs observed in a patient during the first cycle of treatment will be used for the dose escalation decision.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.