Background: Docetaxel (Taxotere) and cisplatin are two of the most active single agents used in the treatment of solid tumors. We examined the feasibility of using a combination of docetaxel and cisplatin for the treatment of unknown primary carcinoma in order to prepare a larger scale prospective study.
Methods: Eligible patients were aged 18 to 75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less and a life expectancy of 8 weeks or more, and had been diagnosed as having unknown primary carcinoma by the required examinations. Patients were not permitted to have received prior chemotherapy and had to have measurable lesions. Docetaxel (60 mg/m(2)) was given intravenously over a 1-h period immediately before cisplatin (80 mg/m(2)), which was given intravenously over a 2-h period, every 3 weeks. Premedication included dexamethasone, granisetron, and standard hyperhydration.
Results: Twenty-six treatment courses in five patients were tested according to the protocol and feasibility was assessed. Adverse events observed included grade 4 neutropenia, leukopenia, grade 3 nausea/vomiting, grade 2 diarrhea, and mucositis. These adverse events were well tolerated, reversible, and manageable. Doses were not reduced and all injections were given or their due date without any delay in all patients. Four patients achieved a partial response and one had stable disease.
Conclusion: Treatment of patients with unknown primary carcinoma with a combination of docetaxel and cisplatin is feasible. Conduct of a phase II trial of this regimen is warranted.