A Phase II Trial of Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Neuroendocrine Carcinoma of the Skin (Merkel Cell Carcinoma)

Pts. must have histologically proven diagnosis of Merkel cell carcinoma which is unresectable, either local/regional or metastatic disease; pts must have bidimensionally measurable disease; pts. must have AGC >= 1,500/ul and platelet count of >= 100,000/ul; PS 0-2; pts. with CNS mets are eligible as long as they have another site which is measurable; pts. must not have rec'd prior biologics or immunotherapy; pts. must not have recv'd chemo for metastatic disease; pts. may have rec'd prior adjuvant chemo except for the agents in this study; pts. with pleural effusions or ascites are not eligible due to side effects of methotrexate; pts. may have rec'd prior surgery if completed at least 14 days prior to registration; pts. must not be planning to receive concurrent chemo, hormonal, immuno or other therapy while on this protocol (except for G-CSF as outlined in Section 8.3); pts. may have rec'd prior RT, however, if all known sites of disease have been previously radiated, there must be objective evidence of progression for the pt. to be eligible.