Vorinostat and Doxorubicin in Treating Patients With Metastatic or Locally Advanced 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 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.

Key facts

Study ID

NCT00331955

Run by

National Cancer Institute (NCI)

People needed

40

Starts

2006-03-01

Last updated by the study team

2013-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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