Randomised phase II study of methotrexate (MTX) versus methotrexate plus lonidamine (MTX + LND) in recurrent and/or metastatic carcinoma of the head and neck.

Abstract

Between March 1990 and March 1992, 89 patients with recurrent and/or metastatic squamous cell cancer of the head and neck were randomised to receive either intravenous methotrexate (MTX) at a weekly dose of 40 mg/m2 plus lonidamine (LND) given orally at a starting dose of 75 mg three times daily for 3 days and then at a dose of 150 mg three times daily (arm MTX + LND) or methotrexate alone (arm MTX) at the same doses as arm MTX + LND. Complete remissions were observed in 10.5% of the patients in arm MTX + LND, and partial remissions in another 15.8%, yielding a 26.3% response rate. In arm MTX, only partial remissions were observed, yielding an overall response rate of 18.2%. Haematological toxicity was mild in both groups. Mild testicular pain (21%) and myalgias (31%) occurred only in patients treated with LND.

• Authors: E Colella, M Merlano, F Blengio, F Angelini, G P Ausili Cefaro, F Scasso, V Lo Russo, S Cirulli, D Giannarelli, F Cognetti
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 30A Issue 7 Pg. 928-30 ( 1994) ISSN: 0959-8049 [Print] England
• PMID: 7946585 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)

Chemical References

• Indazoles
• lonidamine
• Methotrexate

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy)
• Female
• Head and Neck Neoplasms (drug therapy, secondary)
• Humans
• Indazoles (administration & dosage, adverse effects)
• Male
• Methotrexate (administration & dosage, adverse effects)
• Middle Aged
• Neoplasm Recurrence, Local