title: Phase I feasibility study of intraperitoneal cisplatin and intravenous paclitaxel followed by intraperitoneal paclitaxel in untreated ovarian, fallopian tube, and primary peritoneal carcinoma: a gynecologic oncology group study.
abstract: OBJECTIVE
  Intraperitoneal chemotherapy has shown a survival advantage over intravenous chemotherapy for women with newly diagnosed optimally debulked epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. However, significant toxicity has limited its acceptance. In an effort to reduce toxicity, the Gynecologic Oncology Group conducted a Phase I study to evaluate the feasibility of day 1 intravenous (IV) paclitaxel and intraperitoneal (IP) cisplatin followed by day 8 IP paclitaxel on an every 21-day cycle.
  
  
  METHODS
  Patients with Stage IIB-IV epithelial ovarian, fallopian tube, primary peritoneal carcinomas or carcinosarcoma received paclitaxel 135mg/m(2) IV over 3h followed by cisplatin 75mg/m(2) IP on day 1 and paclitaxel 60 mg/m(2) IP on day 8 of a 21 day cycle with 6 cycles planned. Dose-limiting toxicity (DLT) was defined as febrile neutropenia or dose-delay of greater than 2 weeks due to failure to recover counts, or Grade 3-5 non-hematologic toxicity occurring within the first 4 cycles of treatment.
  
  
  RESULTS
  Twenty of 23 patients enrolled were evaluable and nineteen (95%) completed all six cycles of therapy. Three patients experienced a DLT consisting of infection with normal absolute neutrophil count, grade 3 hyperglycemia, and grade 4 abdominal pain.
  
  
  CONCLUSIONS
  This modified IP regimen which administers both IV paclitaxel and IP cisplatin on day one, followed by IP paclitaxel on day eight, of a twenty-one day cycle appears feasible and is an attractive alternative to the intraperitoneal treatment regimen administered in GOG-0172.
authors.affiliation: The Warren Alpert Medical School of Brown University, Providence, RI 02905, USA. ddizon@wihri.org
authors.forename: Don S
authors.initials: DS
authors.lastname: Dizon
authors.forename: Michael W
authors.initials: MW
authors.lastname: Sill
authors.forename: Natalie
authors.initials: N
authors.lastname: Gould
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Rubin
authors.forename: S Diane
authors.initials: SD
authors.lastname: Yamada
authors.forename: Robert L
authors.initials: RL
authors.lastname: Debernardo
authors.forename: Robert S
authors.initials: RS
authors.lastname: Mannel
authors.forename: Eric L
authors.initials: EL
authors.lastname: Eisenhauer
authors.forename: Linda R
authors.initials: LR
authors.lastname: Duska
authors.forename: Paula M
authors.initials: PM
authors.lastname: Fracasso
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010534:Peritoneal Neoplasms / Q000188:drug therapy*
chemical_list: D017239:Paclitaxel; D002945:Cisplatin