Vorinostat, Paclitaxel, and Carboplatin in Treating Patients With Advanced or Refractory Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
This phase I trial is studying the side effects and best dose of vorinostat when given together with paclitaxel and carboplatin in treating patients with advanced or refractory solid tumors. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with paclitaxel and carboplatin may kill more tumor cells
Key facts
- Study ID
- NCT00287937
- Run by
- National Cancer Institute (NCI)
- People needed
- 30
- Starts
- 2005-07-01
- Last updated by the study team
- 2013-02-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed solid tumor
- No untreated brain metastases
- Patients with stable brain disease (no concurrent corticosteroids) ≥ 4 weeks after completion of appropriate therapy are eligible
- ECOG performance status ≤ 2 OR Karnofsky performance status 60-100%
- Life expectancy > 12 weeks
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin normal
- AST/ALT ≤ 2.5 times upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double barrier contraception for at least 1 week before, during, and for at least 2 weeks after study participation
- No peripheral neuropathy > grade 1
- No history of allergic reactions to paclitaxel
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
- No inability to take oral medications on a continuous basis
- No psychiatric illness or social situation that would limit compliance with this study
- No ongoing or active infection
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No other uncontrolled illness
- No more than 2 prior chemotherapy regimens for advanced/metastatic disease
Where it is running
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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