Clinical trial · Interventional
Vorinostat, Paclitaxel, and Carboplatin in Treating Patients With Advanced or Refractory Solid Tumors
Phase I Study Of Suberoylanilide Hydroxamic Acid (SAHA) (NSC 701852) in Combination With Paclitaxel /Carboplatin for Advanced and Refractory Solid Malignancies
- 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 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
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vorinostat, paclitaxel, carboplatin)
- description
- Patients receive oral SAHA once or twice daily on days 1-14\* and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have stable disease after the completion of 6 courses may receive single-agent SAHA at the discretion of the treating physician.
- interventionNames
- Drug: vorinostat
- Drug: paclitaxel
- Drug: carboplatin
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- MTD of vorinostat defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT
- timeFrame
- 21 days
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Adjuvant chemotherapy administered ≥ 2 years prior to study entry is not considered a prior chemotherapy regimen for purposes of this study * No prior therapy with paclitaxel * No chemotherapy or radiotherapy within the past 3 weeks (6 weeks for nitrosoureas or mitomycin C) and recovered * At least 4 weeks since prior valproic acid * No other concurrent anticancer therapies or agents * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent oral contraceptives * No concurrent prophylactic growth factors
References
Publications (0)
Data not yet available