title: Phase II study of troxacitabine (BCH-4556) in patients with advanced non-small-cell lung cancer.
abstract: Troxacitabine. a promising new L-nucleoside, inhibits DNA polymerase and leads to complete DNA chain termination. The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) conducted a phase II study to assess the efficacy and toxicity of troxacitabine in untreated patients with advanced non-small-cell lung cancer (NSCLC). Previously untreated patients were eligible if they had inoperable stage IIIB or IV NSCLC, ECOG PS < or = 2, adequate hematology and biochemistry, and at least one bidimensionally measurable lesion. Patients with prior malignancy or brain metastases were excluded. Troxacitabine (10 mg/m(2)) was administered intravenously over 30 minutes every 3 weeks. Between June 1999 and May 2000, 17 eligible patients received treatment. Patient characteristics included: median age 64 years; female 41%; stage IV (94%); PS 0 (12%), 1 (59%), and 2 (29 %), 3 or more disease sites (59%). In 17 patients, there were 8 stable disease, 9 disease progression, and no objective responses. Median duration of stable disease was 3.6 months (range = 2.0-7.1). A total of 56 cycles were administered (median = 3), and 88% of patients received 90% or more of the planned dose intensity. The majority (82%) of patients experienced skin rash. Hematologic and biochemical toxicities, grade 3/4 (%) were: granulocytopenia (41), anemia (12), thrombocytopenia (6), and hyperglycemia (6). Troxacitabine appears to have little activity in NSCLC in the dose and schedule tested.
authors.affiliation: National Cancer Institute of Canada (Clinical Trials Group), Kingston, Ontario, Canada. sdent@ottawahospital.on.ca
authors.forename: S F
authors.initials: SF
authors.lastname: Dent
authors.forename: A
authors.initials: A
authors.lastname: Arnold
authors.forename: D J
authors.initials: DJ
authors.lastname: Stewart
authors.forename: S
authors.initials: S
authors.lastname: Gertler
authors.forename: J
authors.initials: J
authors.lastname: Ayoub
authors.forename: G
authors.initials: G
authors.lastname: Batist
authors.forename: G
authors.initials: G
authors.lastname: Goss
authors.forename: A
authors.initials: A
authors.lastname: Nevile
authors.forename: D
authors.initials: D
authors.lastname: Soulieres
authors.forename: J
authors.initials: J
authors.lastname: Jolivet
authors.forename: L
authors.initials: L
authors.lastname: McLntosh
authors.forename: L
authors.initials: L
authors.lastname: Seymour
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003596:Cytosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004148:Dioxolanes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
chemical_list: D000970:Antineoplastic Agents; D004148:Dioxolanes; C074908:troxacitabine; D003596:Cytosine