Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group.

Abstract

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.

• Authors: Cheryl A Brewer, John A Blessing, Robert A Nagourney, Mark Morgan, Parviz Hanjani
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 103 Issue 2 Pg. 446-50 (Nov 2006) ISSN: 0090-8258 [Print] United States
• PMID: 16643994 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural)

Chemical References

• Deoxycytidine
• Cisplatin
• Gemcitabine

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Cisplatin (administration & dosage, adverse effects)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Drug Resistance, Neoplasm
• Female
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Ovarian Neoplasms (drug therapy)
• Peritoneal Neoplasms (drug therapy)
• Gemcitabine