Phase II trial of piritrexim and DTIC using an alternating dose schedule in metastatic melanoma

• Published in: American journal of clinical oncology Vol. 18; no. 6; p. 488
• Main Authors: Feun, L G, Robinson, W A, Savaraj, N, Gonzalez, R, Liebmann, A, Offenhauser, K, Clendeninn, N J
• Format: Journal Article
• Language: English
• Published: United States 01-12-1995
• Subjects: Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Dacarbazine - administration & dosage; Dacarbazine - adverse effects; Drug Administration Schedule; Female; Humans; Infusions, Intravenous; Liver Neoplasms - drug therapy; Lung Neoplasms - drug therapy; Male; Melanoma - drug therapy; Middle Aged; Pyrimidines - administration & dosage; Pyrimidines - adverse effects; Remission Induction
• ISSN: 0277-3732
• DOI: 10.1097/00000421-199512000-00006

A Phase II trial was conducted in patients with metastatic malignant melanoma with DTIC 250 mg/m2 intravenously for 5 days alternating monthly with Piritrexim (PTX) using an intermittent, low-dose oral administration schedule. PTX was administered at a starting dose of 25 mg orally three times per day for 5 days weekly for 3 weeks followed by 1 week of rest. Twenty-one patients were entered into the study. Among the 17 patients assessable for response, 1 patient had a minor response, and 3 patients had stable disease. No partial or complete response were observed. Toxicity was tolerable and consistent mainly of myelosuppression. Using this alternating dose schedule, PTX and DTIC produced little response in metastatic melanoma.