Phase I clinical and pharmacologic trial of carboplatin daily for 5 days
Van Echo, D.A.; Egorin, M.J.; Whitacre, M.Y.; Olman, E.A.; Aisner, J.
Cancer Treatment Reports 68(9): 1103-1114
1984
ISSN/ISBN: 0361-5960 PMID: 6383605 Document Number: 223556
Patients (22) with refractory tumors received 64 courses of i.v. bolus carboplatin every day .times. 5, every 4-5 wk. All patients are evaluable for toxicity and 18 are evaluable for response. For solid tumor phase II studies, a dose of 77 mg/m2 per day .times. 5 is recommended for patients who have received prior chemotherapy. Patients with no prior chemotherapy experience should receive 99 mg/m2 per day .times. 5. The major dose-limiting side effect is dose-related thrombocytopenia. Courses of carboplatin on this schedule should be repeated every 5 wk to avoid cumulative wbc count toxicity, since leukopenia frequently did not occur until day 28. Other toxic effects observed were nausea and vomiting and lower extremity myalgias and arthralgias. There was no evidence of hearing loss, mucosal damage or changes in liver or renal function tests of any patient while in this study. Therapeutic responses were seen in 4 patients: 1 partial response in renal cancer of 9+ mo. duration: 1 partial response in head and neck cancer of 7+ mo. duration; and objective responses in melanoma and colorectal carcinoma of 6 mo. duration.