A phase II evaluation of pemetrexed (Alimta, LY231514, IND #40061) in the treatment of recurrent or persistent endometrial carcinoma: a phase II study of the Gynecologic Oncology.
OBJECTIVE
To estimate the anti-tumor activity of pemetrexed in patients with advanced or recurrent carcinoma of the endometrium and to determine the nature and degree of toxicity.


METHODS
A multicenter phase II trial was conducted by the Gynecologic Oncology Group (GOG). Patients must have had advanced or recurrent measurable carcinoma of the endometrium and failed one prior chemotherapy regimen. Pemetrexed at a dose of 900 mg/m(2) was administered as an IV infusion over 10 min every 21 days.


RESULTS
From May 1, 2006 to July 31, 2007, 27 patients were entered by 10 member institutions of the GOG with two patients being deemed ineligible. A total of 101 cycles were administered with 28% of patients receiving five or more cycles. Overall, the treatment was well tolerated. More serious toxicities (grade 3 and 4) included anemia in 20%, leukopenia in 40%, neutropenia in 48%, and constitutional in 16%. No treatment-related deaths were reported. One patient (4%) had a partial response. Eleven patients (44%) had stable disease and eleven (44%) patients had increasing disease. Response could not be assessed in two patients (7%). Median progression-free survival was 2.7 months and overall survival was 9.4 months.


CONCLUSIONS
Pemetrexed has minimal activity in the treatment of recurrent or persistent endometrial carcinoma at the dose and schedule tested.
Miller
David Scott
DS
Division of Gynecologic Oncology, University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd., Room J7-124, Dallas, TX 75390-9032, USA. david.miller@utsouthwestern.edu
Blessing
John A
JA
Drake
Richard D
RD
Higgins
Robert
R
McMeekin
D Scott
DS
Puneky
Louis V
LV
Krasner
Carolyn N
CN
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D016889:Endometrial Neoplasms / Q000188:drug therapy*; D005260:Female; D005971:Glutamates / Q000009:adverse effects / Q000627:therapeutic use*; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D000068437:Pemetrexed
D000964:Antimetabolites, Antineoplastic; D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine