Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer
This trial will examine the upregulation of dexamethasone-inducible genes in the tumors of
ovarian cancer patients undergoing surgical debulking. A core biopsy of tumor will be taken
at the first opportune time during surgery. Dexamethasone 20 mg IV will then be
administered, and a second biopsy taken 30 minutes later. Samples at two and four hours
later will also be obtained if surgery is still in progress and biopsiable tumor remains.
Tissue will be snap-frozen. Subsequently tumor will be microdissected out from stroma, and
tumor RNA will be extracted for gene expression profiling. Sixteen patients with epithelial
ovarian cancer receiving dexamethasone will be studied, and an additional eight patients
with epithelial ovarian cancer will receive a small saline (placebo) injection and serve as
controls. Enrollment is limited to those patients with a serum albumin of at least 3.0 g/dL
to minimize any theoretical adverse effect of a single dose of dexamethasone on wound
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare changes in expression of glucocorticoid-induced genes that may be involved in cell survival signaling in the tumors of ovarian cancer patients before and after an intraoperative dose of 20 mg dexamethasone.
Gini Fleming, MD
Gralla, R. J., Osoba, D., Kris, M. G., Kirkbride, P., Hesketh, P. J., et al.: Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. American Society of Clinical Oncology. J Clin Oncol 1999; 17(9): 2971-94.
United States: Institutional Review Board
|The University of Chicago||Chicago, Illinois 60637|