Phase II study of high-dose methotrexate in the treatment of patients with non-small cell carcinoma of the lung: an Eastern Cooperative Oncology Group study.

Twenty-eight patients with inoperable non-small cell carcinoma of the lung were treated with high-dose methotrexate with citrovorum factor rescue. One patient (4%) responded with a partial regression of the tumor. Three patients had severe or life-threatening complications: acute renal failure, acute shortness of breath, and bone marrow suppression, respectively. There is 98% confidence that the true response rate for this therapy is less than 20%. The results of this study demonstrate that high-dose methotrexate with citrovorum factor rescue, in the schedule utilized, is not effective in the treatment of patients with non-small cell carcinoma of the lung.