A Pilot Study of Celecoxib in Patients With Grade 2 or 3 Uterine Cancers
Status:
Terminated
Trial end date:
2004-03-01
Target enrollment:
Participant gender:
Summary
Expression of COX-II has been identified in many types of human cancers. Uterine cancer is
the most common gynecologic cancer in the US and there has been an increase in uterine cancer
deaths over the past decade mainly due to the difficulty in treating recurrences in the more
aggressive histologic types. The study co-investigators have also identified COX-II
expression in grade 2 and 3 endometrioid-type, clear cell, and papillary serous types of
uterine cancers. Upregulation of COX-II may control the cell cycle by regulating the
proliferative capacity of neoplastic endometrial cells. This is a Phase II pre-post
intervention comparison study in eligible patients looking at the effects of a COX-II
inhibitor on uterine cancer. The patients whose endometrial biopsy shows grade 2 or 3
endometrioid-type, clear cell, and papillary serous types of uterine cancers will be put on a
selective COX-II inhibitor, Celebrex (Celecoxib) until the day of their surgery. We
hypothesize that Celecoxib will downregulate the expression of COX-II in these tumor types as
it does in other similar tumors. We also hypothesize that apoptosis, as measured with the
TUNEL assay, will be increased in areas with less COX-II expression and should be inversely
proportional to cellular p21 expression. We hypothesize COX-related gene expression will be
altered thus suggesting an up- or down-regulation of these genes in the end-organ tissue.
Documenting downregulation of COX-II enzyme and altered gene expression in endometrial
carcinoma after treatment with Celecoxib may result in further prospective studies using
selective COX-II inhibitors as effective, well-tolerated chemotherapeutic agents in these
uterine cancers that are resistant to many current therapies.