title: A phase I trial of a 3-day topotecan Q 21 days for recurrent epithelial cancers of the ovary, fallopian tube, and peritoneum.
abstract: OBJECTIVE
  This trial was undertaken to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of topotecan that can be administered for 3 days q 21 days. A 3-day schedule is more convenient and less expensive than standard 5-day dosing.
  
  
  METHODS
  Patients with recurrent epithelial ovary, tubal, or peritoneal carcinoma were treated with escalating doses of topotecan beginning at 2.50 mg/m(2) as an outpatient days 1-3 q 21 days. Colony stimulating factors were not employed prophylactically, but could be added for grade 4 marrow toxicity.
  
  
  RESULTS
  Twenty patients with a median age of 61 (range 46-80) and performance status of 0 or 1 were entered. All patients had received at least one prior paclitaxel/platinum regimen; 6 had received two. Ninety-one cycles were delivered (median = 6) and 98.9% were on schedule. Grade 4 neutropenia was seen in 17 of 20 patients (85%) in cycle 1 and in 38 of 91 (41.8%) total cycles. Sixteen of 20 patients (80%) started G-CSF on cycle 2. Two of 91 (2.2%) cycles had grade 4 thrombocytopenia. Four cycles (4.4%) were associated with febrile neutropenia. Two patients experienced grade 4 neurotoxicity (DLT) at 4.25 mg/m(2). Other nonhematologic toxicity was mild.
  
  
  CONCLUSIONS
  Topotecan can be safely administered on schedule as an outpatient days 1-3 q 21 days. Neurotoxicity was the DLT when G-CSF was added; the MTD was 3.75 mg/m(2). There was minimal other nonhematologic toxicity. Neutropenia was predictable and easily managed with G-CSF. Febrile neutropenia was uncommon and thrombocytopenia was rare at the doses evaluated.
authors: Gynecologic Oncology Associates, Newport Beach, California 92663, USA.
authors: J V
authors: JV
authors: Brown
authors: W A
authors: WA
authors: Peters
authors: M A
authors: MA
authors: Rettenmaier
authors: B Y
authors: BY
authors: Karlan
authors: R A
authors: RA
authors: Dillman
authors: M R
authors: MR
authors: Smith
authors: C W
authors: CW
authors: Drescher
authors: J P
authors: JP
authors: Micha
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D004848:Epithelium / Q000473:pathology; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006402:Hematologic Diseases / Q000139:chemically induced / Q000188:drug therapy; D006801:Humans; D007262:Infusions, Intravenous; D007710:Klebsiella Infections / Q000139:chemically induced; D007711:Klebsiella pneumoniae; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D012894:Sleep Stages / Q000187:drug effects; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D000970:Antineoplastic Agents; D004791:Enzyme Inhibitors; D016179:Granulocyte Colony-Stimulating Factor; D019772:Topotecan