title: A phase II trial of paclitaxel poliglumex in recurrent or persistent ovarian or primary peritoneal cancer (EOC): a Gynecologic Oncology Group Study.
abstract: OBJECTIVE
  To estimate the anti-tumor activity and toxicity of paclitaxel poliglumex (PPX) in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (EOC) in second or third line treatment.
  
  
  METHODS
  Twenty-five patients received PPX at 235 mg/m(2) every 21 days (Cohort 1). At a planned analysis following first stage accrual, the dose was reduced to 175 mg/m(2) Cohort 2) for additional accrual to 78 patients. RECIST and CTC toxicity criteria were used.
  
  
  RESULTS
  Patients received PPX in the second line (15%) and third line (85%) setting. In cohort 2, 25 out of 47 determined cases (53%) were platinum resistant and 17 out of 43 determined cases (40%) were taxane-resistant. The overall response rates for cohort 2 were 0/49 (0%) CR, 8/49 (16%) PR, and 20/49 (41%) SD. The median progression-free survival (PFS) was 2.8 months (95% CI 1.48-4.8 months) and median overall survival (OS) was 15.4 months. The most frequent grade III or IV toxicities in cohort 2 were: neutropenia (24%/20%), constitutional (8%/0%), gastrointestinal (6%/0%), and neuropathy (24%/0%).
  
  
  CONCLUSIONS
  PPX at 175 mg/m(2) every 21 days has a modest activity of limited duration when given as second or third line therapy in patients with epithelial ovarian or primary peritoneal cancer. The incidence of neuropathy using this dose in recurrent ovarian cancer is higher than predicted from studies in other tumors with PPX. The Gynecology Oncology Group (GOG) is currently exploring its use at 135 mg/m(2) every 28 days in a randomized trial evaluating maintenance chemotherapy in first remission.
authors.affiliation: Department of Medicine, Gynecologic Medical Oncology Service, Memorial Sloan-Kettering Center, New York, NY 10021, USA. Sabbatip@MSKCC.org
authors.forename: Paul
authors.initials: P
authors.lastname: Sabbatini
authors.forename: Michael W
authors.initials: MW
authors.lastname: Sill
authors.forename: David
authors.initials: D
authors.lastname: O'Malley
authors.forename: Lisa
authors.initials: L
authors.lastname: Adler
authors.forename: Angeles Alvarez
authors.initials: AA
authors.lastname: Secord
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D011099:Polyglutamic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D011099:Polyglutamic Acid; D017239:Paclitaxel; C509139:paclitaxel poliglumex