title: A multicenter, non-randomized, phase II study of docetaxel and carboplatin administered every 3 weeks as second line chemotherapy in patients with first relapse of platinum sensitive epithelial ovarian, peritoneal or fallopian tube cancer.
abstract: BACKGROUND
  In patients with ovarian cancer relapsing at least 6 months after end of primary treatment, the addition of paclitaxel to platinum treatment has been shown to improve survival but at the cost of significant neuropathy. In the first line setting, the carboplatin-docetaxel combination was as effective as the combination of carboplatin and paclitaxel but with less neurotoxicity. This study was initiated to evaluate the feasibility of carboplatin with docetaxel as second line treatment in patients with ovarian, peritoneal or fallopian tube cancer.
  
  
  METHODS
  Patients with stage IC-IV epithelial ovarian, peritoneal or fallopian tube cancer were enrolled at the first relapse after at least 6 months since completion of the first line treatment. Docetaxel 75 mg/m2 was given as an one hour IV infusion followed immediately by carboplatin (AUC=5) given as a 30-60 min. IV infusion on day 1 and repeated every 3 weeks for 6-9 courses. Primary endpoint was toxicity; secondary endpoints were response rate and the time to progression.
  
  
  RESULTS
  A total of 74 patients were included. Of these, 50 patients received 6 or more cycles, 13 received 3-5 courses and 11 received less than 3 courses. A total of 398 cycles were given. Grade 3/4 neutropenia was seen in 80% (59 of 74) patients with an incidence of febrile neutropenia of 16%. Grade 2/3 sensory peripheral neuropathy occurred in 7% of patients, but no grade 4 sensory peripheral neuropathy was observed. Sixty patients were evaluable for response. The overall response rate was 70% with 28% complete responses in the response evaluable patient population. Median progression-free survival was 12.4 months (95% CI 10.4-14.4).
  
  
  CONCLUSIONS
  The three-weekly regimen of docetaxel in combination with carboplatin was feasible and active as second-line treatment of platinum-sensitive ovarian, peritoneal and Fallopian tube cancer. The major toxicity was neutropenia, while the frequency of peripheral neuropathy was low.
authors.forename: Yun
authors.initials: Y
authors.lastname: Wang
authors.forename: Jørn
authors.initials: J
authors.lastname: Herrstedt
authors.forename: Hanne
authors.initials: H
authors.lastname: Havsteen
authors.forename: Rene
authors.initials: R
authors.lastname: DePoint Christensen
authors.forename: Mansoor Raza
authors.initials: MR
authors.lastname: Mirza
authors.forename: Bente
authors.initials: B
authors.lastname: Lund
authors.forename: Johanna
authors.initials: J
authors.lastname: Maenpaa
authors.affiliation: Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, PB 4953 Nydalen 0424, Oslo, Norway. gunnar.b.kristensen@gmail.com.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Kristensen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002277:Carcinoma / Q000188:drug therapy*; D000077216:Carcinoma, Ovarian Epithelial; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000209:etiology; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D004354:Drug Screening Assays, Antitumor; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D011446:Prospective Studies; D020886:Somatosensory Disorders / Q000139:chemically induced; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin