title: Phase II study of CT-2103 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of CT-2103, a novel conjugate of paclitaxel and poly-L-glutamic acid, in heavily pretreated patients with recurrent ovarian, fallopian tube, or peritoneal cancer.
  
  
  METHODS
  Ninety-nine patients with measurable disease received intravenous CT-2103 at 175 mg/m2 of conjugated paclitaxel over 10 minutes every 3 weeks without routine premedications. Platinum-sensitive (n = 42) and platinum-refractory or platinum-resistant patients (n = 57) were enrolled. Thirty-nine patients (39%) had received one or two prior regimens, and 60 patients (61%) had received between three and 12 regimens.
  
  
  RESULTS
  In 99 patients, the median number of cycles was three (range, one to 14 cycles). The response rate (RR) for all patients was 10% (10 of 99 patients), with median time to disease progression (TTP) of 2 months. The RR (partial response) in platinum-sensitive and platinum-resistant patients was 14% (six of 42 patients) and 7% (four of 57 patients), respectively. In patients with only one or two prior regimens, the RR in platinum-sensitive and platinum-resistant patients was 28% (five of 18 patients) and 10% (two of 21 patients), with a median TTP of 4 and 2 months, respectively. Grade 2 (15 patients) or 3 (15 patients) neuropathy was reported in 30 patients (30%). Grade 2 hypersensitivity occurred in eight patients (8%) who were subsequently treated with premedications; one patient had grade 3 hypersensitivity and was removed. Grade 2 alopecia was absent.
  
  
  CONCLUSIONS
  CT-2103 is active in patients with recurrent ovarian cancer. Neurotoxicity in these heavily pretreated patients was more frequent than predicted from phase I trials. Further study to define toxicity and efficacy in patients with less prior therapy is ongoing.
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. sabbatip@mskcc.org
authors.forename: Paul
authors.initials: P
authors.lastname: Sabbatini
authors.forename: Carol
authors.initials: C
authors.lastname: Aghajanian
authors.forename: Don
authors.initials: D
authors.lastname: Dizon
authors.forename: Sybil
authors.initials: S
authors.lastname: Anderson
authors.forename: Jakob
authors.initials: J
authors.lastname: Dupont
authors.forename: John V
authors.initials: JV
authors.lastname: Brown
authors.forename: William A
authors.initials: WA
authors.lastname: Peters
authors.forename: Andrew
authors.initials: A
authors.lastname: Jacobs
authors.forename: Aminder
authors.initials: A
authors.lastname: Mehdi
authors.forename: Saul
authors.initials: S
authors.lastname: Rivkin
authors.forename: Amy J
authors.initials: AJ
authors.lastname: Eisenfeld
authors.forename: David
authors.initials: D
authors.lastname: Spriggs
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009422:Nervous System Diseases / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000031:analogs & derivatives; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011099:Polyglutamic Acid / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use* / Q000031:analogs & derivatives; D043823:Taxoids / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D043823:Taxoids; D011099:Polyglutamic Acid; D017239:Paclitaxel; C509139:paclitaxel poliglumex