Clinical trial · Interventional
Vorinostat and Doxorubicin in Treating Patients With Metastatic or Locally Advanced Solid Tumors
Phase I Trial of Vorinostat (NSC-701852, Suberoylanilide Hydroxamic Acid) and Doxorubicin (NSC-123127, Adriamycin)
NCT00331955CI-TRIAL-00011187completedPhase 1ClinicalTrials.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 phase I trial is studying the side effects and best dose of vorinostat when given together with doxorubicin in treating patients with metastatic or locally advanced 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 doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may help doxorubicin work better by making tumor cells more sensitive to the drug.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vorinostat, doxorubicin hydrochloride)
- description
- Patients receive oral vorinostat twice daily for 5 doses on days 1-3, 8-10, and 15-17 and doxorubicin hydrochloride IV on days 3, 10, and 17. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 6 courses of treatment may continue to receive vorinostat alone in the absence of disease progression.
- interventionNames
- Drug: doxorubicin hydrochloride
- Drug: vorinostat
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Safety and tolerability as assessed by NCI CTCAE v3.0
- timeFrame
- Up to 30 days after completion of treatment
- measure
- Maximum tolerated dose (MTD) of vorinostat as assessed by NCI CTCAE v3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed solid tumor malignancies for which no curative therapy exists * Measurable or evaluable disease with tumor that is accessible to biopsy as determined by CT scan or ultrasound * Skin, lymph nodes, or chest wall lesions are allowed provided measurements are confirmed by 2 independent health care professionals * No uncontrolled CNS metastases * Patients with stable CNS metastases (either surgically resected, treated with gamma knife, or stable for 3 months after whole-brain radiotherapy and documented by MRI within the past 4 weeks) are eligible * Willing to undergo pre- and post-vorinostat tumor biopsies * Life expectancy ≥ 3 months * ECOG performance status 0-2 * WBC \> 3,000/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Hemoglobin \> 9.0 g/dL * Platelet count \> 100,000/mm\^3 (transfusion independent) * Creatinine ≤ 2.0 mg/mL * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 1.5 times ULN * LVEF \> 50% * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * Negative pregnancy test * Not pregnant or nursing * No significant active infection (e.g., pneumonia, cellulitis, or wound abscess) * No history of cardiac failure * No history of long QT syndrome (QTc \> 470 msec) * No history of ventricular tachycardia or fibrillation * No history of seizures * No history of allergic reactions attributed to compounds of similar chemical or biological composition to vorinostat or other agents used in the study * More than 3 weeks since prior chemotherapy or radiotherapy (2 weeks for weekly regimens) * More than 2 weeks since prior valproic acid or any other histone deacetylase inhibitors * No prior anthracycline exposure * No other concurrent chemotherapy * No concurrent hormonal therapy except for maintenance therapy with luteinizing-hormone releasing-hormone agonists * No concurrent antiarrhythmics * No concurrent steroids to control brain metastasis * No concurrent colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) during the first course of study treatment * No other concurrent investigational agents for primary disease
References
Publications (0)
Data not yet available
No reference posted for this study.