title: Treatment of recurrent platinum resistant ovarian or peritoneal cancer with gemcitabine and doxorubicin: A phase I/II trial of the Puget Sound Oncology Consortium (PSOC 1602).
abstract: OBJECTIVE
  This study was undertaken to determine the degree of toxicity, response rate, and evaluate quality of life (QOL) in women receiving gemcitabine in combination with doxorubicin for platinum-resistant and refractory ovarian or peritoneal cancer.
  
  
  METHODS
  This was a phase I/II prospective trial.
  
  
  METHODS
  Nine patients were enrolled in the phase I portion. Initial doses of gemcitabine, 800 mg/m(2) intravenously on days 1, 8, and 15, and doxorubicin, 25 mg/m(2) intravenously on days 1, 8, and 15 in a 28-day cycle resulted in dose limiting toxicity secondary to thrombocytopenia and neutropenia. Forty patients were treated on the phase II portion with gemcitabine, 700 mg/m(2) intravenously on days 1 and 8, and doxorubicin 20 mg/m(2) intravenously on days 1 and 8 with granulocyte colony-stimulating factor administered on days 2 to 7 and 9 to 14 in a 21-day cycle. QOL was assessed with Fact-O.
  
  
  RESULTS
  The median number of previous chemotherapy regimens for the 49 women was 2 (range 1-5). There were 2 complete and 9 partial responses, for an overall response rate of 24%. Median duration of response was 5 months. Fourteen women (31%) had stable disease with median duration of response of 5 months. Median survival for the entire group was 12 months. Toxicity was primarily hematologic, and only 3 patients discontinued therapy because of toxicity. QOL surveys indicated that this was a well-tolerated regimen.
  
  
  CONCLUSIONS
  The combination of gemcitabine and doxorubicin can be safely administered. Overall, approximately 55% of women with platinum-resistant ovarian or peritoneal cancer benefit from this regimen with response or stabilization of disease.
authors.affiliation: Department of Obstetrics and Gynecology, University of Washington School of Medicine, Seattle, 98195-6460, USA.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Goff
authors.forename: Tove
authors.initials: T
authors.lastname: Thompson
authors.forename: Benjamin E
authors.initials: BE
authors.lastname: Greer
authors.forename: Andrew
authors.initials: A
authors.lastname: Jacobs
authors.forename: Barry
authors.initials: B
authors.lastname: Storer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000523:psychology; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000523:psychology; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000523:psychology; D010984:Platinum; D011446:Prospective Studies; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D014861:Washington; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D010984:Platinum; D004317:Doxorubicin; D000093542:Gemcitabine