Early clinical study of an intermittent schedule for maytansine (NSC-153858) : brief communication
Eagan, R.T.; Ingle, J.N.; Rubin, J.; Frytak, S.; Moertel, C.G.
Journal of the National Cancer Institute 60(1): 93-96
1978
ISSN/ISBN: 0027-8874 PMID: 628025 Document Number: 127148
Maytansine, an ansa macrolide, was evaluated in an early clinical trial in 40 adult patients with various solid tumors. Severe nausea and vomiting, sometimes associated with watery diarrhea and abdominal cramps, and liver function abnormalities, mainly elevation of serum glutamic--oxaloacetic transaminase levels, together constituted what we considered dose-limiting toxicity. Mild hematologic toxicity (mainly thrombocytopenia), neurotoxicity, and possibly cardiac toxicity were also noted. No antitumor effect was seen. An iv dose of 0.750 mg/m2 on days 1, 3, and 5 (total dose, 2.25 mg/m2) repeated every 4 weeks is recommended for Phase II trials.