Journal of Clinical Oncology, Vol 1, 621-626, Copyright © 1983 by American Society of Clinical Oncology
Phase I study of carboplatin given on a five-day intravenous schedule
M Rozencweig, C Nicaise, M Beer, N Crespeigne, M Van Rijmenant, L Lenaz and Y Kenis
Twenty-six adult patients were entered in a phase I trial of carboplatin, a
new cisplatin derivative with reduced potential for nephrotoxicity. All
patients had solid tumors and the median World Health Organization
performance score was 2 (0-3). Twelve patients had not received prior
chemotherapy. The drug was administered as a 15- minute IV infusion,
without pre- or posthydration, at daily doses of 40- 125 mg/m2 for five
consecutive days. Antiemetics were given only if needed. Thrombocytopenia
and neutropenia were dose related and dose limiting. One patient died from
septic shock at the highest dose level. Nonhemolytic anemia was also
encountered. Nausea and vomiting were experienced by most patients but
gastrointestinal intolerance was severe in only two patients. One patient
had hypercreatininemia, which was minor and rapidly reversible. Other toxic
effects consisted of negligible fatigue, paresthesia, pruritus, local pain,
stomatitis, headache, and alopecia. Although none of the patients achieved
a partial or complete response, antitumor effect was strongly suggested in
two patients with thyroid and cervix cancer, respectively. Carboplatin is
an attractive candidate for phase II trials. In good- risk patients, such
trials could be initiated at a daily dose of 100 mg/m2 for five consecutive
days every five to six weeks.
