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Medline ® Abstract for Reference 26

of 'Medical treatment for relapsed epithelial ovarian, fallopian tubal, or peritoneal cancer: Platinum-resistant disease'

Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group.
Brewer CA, Blessing JA, Nagourney RA, Morgan M, Hanjani P
Gynecol Oncol. 2006;103(2):446. Epub 2006 Apr 27.
OBJECTIVES: To evaluate the safety and efficacy of cisplatin plus gemcitabine in persistent or recurrent platinum-resistant ovarian and primary peritoneal cancer.
STUDY DESIGN: Eligible, consenting subjects with measurable disease and one prior platinum-based regimen, but no prior gemcitabine, were to receive intravenous cisplatin followed by gemcitabine on days 1 and 8 every 28 days.
RESULTS: Between December 2000 and March 2003, 59 patients were enrolled from 24 institutions; two were ineligible. During the first stage of accrual, 27 subjects received cisplatin 30 mg/m2 and gemcitabine 750 mg/m2. In the second stage, gemcitabine was reduced to 600 mg/m2 because of hematologic toxicity at the higher dose. There were 4 complete and 5 partial responses for an overall response rate of 16% (9/57). Thirty-one women (54%) had stable disease. Median time to progression was 5.4 months. Overall survival was 14.9+ months. Grade 4 toxicities were hematologic, except one cutaneous reaction.
CONCLUSIONS: Cisplatin plus gemcitabine, in the doses and schedule employed, has modest activity in this patient population.
UMC Department of Ob/Gyn, Division of Gynecologic Oncology, University of California Irvine and University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216-4505, USA. CABrewer3@ob-gyn.umsmed.edu