Phase II trial of perillyl alcohol (NSC 641066) administered daily in patients with metastatic androgen independent prostate cancer
| Autor: | Emily Robinson, Lynn Van Ummersen, Kurt R. Oettel, George Wilding, Dorothea Horvath, David L. DeMets, Kendra D. Tutsch, Rhoda Z. Arzoomanian, James McGovern, Hamied Rezazadeh, Glenn Liu, Dona Alberti, Howard H. Bailey, Mary Jane Staab |
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| Rok vydání: | 2003 |
| Předmět: |
Male
medicine.medical_specialty Maximum Tolerated Dose Nausea Drug intolerance Administration Oral Antineoplastic Agents Drug Administration Schedule Transforming Growth Factor beta1 Prostate cancer chemistry.chemical_compound Transforming Growth Factor beta Internal medicine Multicenter trial medicine Clinical endpoint Humans Pharmacology (medical) Aged Pharmacology Aged 80 and over business.industry Perillyl alcohol Prostatic Neoplasms Middle Aged medicine.disease Surgery Regimen Treatment Outcome Oncology chemistry Vomiting Androgens Monoterpenes medicine.symptom business |
| Zdroj: | Investigational new drugs. 21(3) |
| ISSN: | 0167-6997 |
| Popis: | Objective. We conducted a phase II multicenter trial of perillyl alcohol in patients with advanced hormone refractory prostate cancer (HRPC). The primary endpoint was to evaluate the 6-month progression-free survival given the potential cytostatic nature of the drug. Secondary objectives included assessing acute and chronic toxicities, as well as measuring objective response rates. Methods. Patients with metastatic androgen-independent prostate cancer that failed at least one prior chemotherapeutic or experimental regimen were eligible. Perillyl alcohol was administered orally at 1200 mg/m2/dose four times daily and continued until disease progression or development of unacceptable toxicity. Results. Fifteen patients were eligible. Six patients received less than one cycle (4 weeks) of drug, four of which stopped because of drug intolerance. Only six patients received more than two cycles of therapy and were considered evaluable for response. Main toxicity included grade 1–2 gastrointestinal intolerance (nausea/vomiting in 60% of the patients) and fatigue (47%). One patient developed a grade 4 hypokalemia that was felt likely attributable to the drug. No objective responses were seen. All patients either progressed or withdrew from the study secondary to drug intolerance before the 6-month time period. Conclusion. Perillyl alcohol administered at this dose and formulation did not have any objective clinical activity in this patient population. |
| Databáze: | OpenAIRE |
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