A phase II study of gemcitabine (gemzar, LY188011) in the treatment of recurrent or persistent endometrial carcinoma: a gynecologic oncology group study.

Abstract

OBJECTIVE:

The study aims to evaluate the anti-tumor activity and toxicity of gemcitabine in patients with persistent or recurrent endometrial carcinoma.

METHODS:

Patients with advanced or recurrent carcinoma of the endometrium previously treated with one chemotherapy regimen were treated on a phase II trial conducted by the Gynecologic Oncology Group (GOG). Gemcitabine was administered as an intravenous infusion at a dose of 800 mg/m² over 30 min on days 1 and 8 every 21 days.

RESULTS:

Twenty-four patients were entered by 11 GOG member institutions. One patient was ineligible due to wrong primary tumor. A total of ninety 21-day cycles of therapy were administered with 35% of patients receiving four or more cycles. All patients had been previously treated with a platinum-based regimen. One patient had a partial response (4%), nine had stable disease (39%), and twelve had increasing disease (52%). The median progression-free survival was 1.7 months. Treatment was generally well tolerated with only 22% of patients experiencing grade 3 or grade 4 hematologic toxicity. There was one treated-related death due to pulmonary toxicity.

CONCLUSION:

Gemcitabine has minimal activity in the treatment of recurrent or persistent endometrial carcinoma at the dose and schedule tested.

• Authors: David L Tait, John A Blessing, James S Hoffman, Kathleen N Moore, Nick M Spirtos, Jason A Lachance, Jacob Rotmensch, David S Miller
• Journal: Gynecologic oncology (Gynecol Oncol) Vol. 121 Issue 1 Pg. 118-21 (Apr 2011) ISSN: 1095-6859 [Electronic] United States
• PMID: 21159366 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: Copyright © 2010 Elsevier Inc. All rights reserved.

Chemical References

• Antimetabolites, Antineoplastic
• Deoxycytidine
• Gemcitabine

Topics

• Adenocarcinoma (drug therapy)
• Adult
• Aged
• Antimetabolites, Antineoplastic (adverse effects, therapeutic use)
• Carcinoma, Endometrioid (drug therapy)
• Deoxycytidine (adverse effects, analogs & derivatives, therapeutic use)
• Endometrial Neoplasms (drug therapy)
• Female
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy)
• Gemcitabine