title: A phase 2 evaluation of irofulven as second-line treatment of recurrent or persistent intermediately platinum-sensitive ovarian or primary peritoneal cancer: a Gynecologic Oncology Group trial.
abstract: This multicenter phase 2 trial was conducted by the Gynecologic Oncology Group to evaluate the activity and the safety of irofulven in patients with recurrent epithelial ovarian cancer. Eligible patients had documented recurrent ovarian cancer 6 to 12 months after receiving a front-line platinum-based regimen and no other chemotherapy. Patients were required to have measurable disease, performance status of 0 to 2, and adequate bone marrow, hepatic, and renal functions before study entry. The dose of irofulven was 0.45 mg/kg intravenously on days 1 and 8 every 21 days. Responses were defined by Response Evaluation Criteria in Solid Tumors. Fifty-five of 61 enrolled patients were evaluable for response and toxicity. There were 7 partial responses (12.7%), and 30 patients (54.6%) had stable disease. Median progression-free and overall survival were 6.4 months (1.3-37.5 months) and 22.1 months or more (2.8-57.8+ months), respectively. Patients received a median of 3 cycles (range, 1-21) of protocol therapy. Grade 4 hematologic toxicity was limited to reversible neutropenia and thrombocytopenia. Grade 4 nonhematologic toxicity was limited to one patient with anorexia and another with hypomagnesemia. Irofulven administered at this dose and schedule was well tolerated but had modest activity as a single agent.
authors.affiliation: Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, USA. russell.schilder@fccc.edu
authors.forename: Russell J
authors.initials: RJ
authors.lastname: Schilder
authors.forename: John A
authors.initials: JA
authors.lastname: Blessing
authors.forename: Mark S
authors.initials: MS
authors.lastname: Shahin
authors.forename: David S
authors.initials: DS
authors.lastname: Miller
authors.forename: Krishnansu Sujata
authors.initials: KS
authors.lastname: Tewari
authors.forename: Carolyn Y
authors.initials: CY
authors.lastname: Muller
authors.forename: David P
authors.initials: DP
authors.lastname: Warshal
authors.forename: Scott
authors.initials: S
authors.lastname: McMeekin
authors.forename: Jacob
authors.initials: J
authors.lastname: Rotmensch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy* / Q000473:pathology; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016879:Salvage Therapy; D012717:Sesquiterpenes / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D012717:Sesquiterpenes; C102714:irofulven; D017239:Paclitaxel; D002945:Cisplatin