title: Difluorodeoxycytidine (dFdC)--gemcitabine: a phase I study.
abstract: Difluorodeoxycytidine (dFdC) demonstrated broad spectrum activity in preclinical models. A phase 1 study utilizing twice weekly injections was conducted in 50 eligible and evaluable patients. Twenty-nine patients received drug by 30 minute infusion at doses of 5-90 mg/m2 and 22, by 5 minute bolus at 30-150 mg/m2. The primary dose limiting toxicities were marrow suppression and flu-like symptomatology. Thrombocytopenia was dose limiting at 75 mg/m2 on the infusion schedule and 150 mg/m2 on the 5 minute schedule. Flu-like symptoms with fever, rigors and malaise occurred the day of injection in many patients. One patient with renal cell carcinoma attained a partial response. Evaluation of the drug's efficacy and schedule dependency continue.
authors.affiliation: Department of Internal Medicine, Wayne State University School of Medicine, Detroit, Michigan 48202-0188.
authors.forename: E A
authors.initials: EA
authors.lastname: Poplin
authors.forename: T
authors.initials: T
authors.lastname: Corbett
authors.forename: L
authors.initials: L
authors.lastname: Flaherty
authors.forename: P
authors.initials: P
authors.lastname: Tarasoff
authors.forename: B G
authors.initials: BG
authors.lastname: Redman
authors.forename: M
authors.initials: M
authors.lastname: Valdivieso
authors.forename: L
authors.initials: L
authors.lastname: Baker
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine