Clinical trial NCT00817479: Tumor Gene Expression in Women With Ovarian Cancer
Official title: Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Cancer
Keywords: Subject has intraabdominal disease either proven or strongly
suspected to be ovarian or primary peritoneal cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study objective is 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 20mg dexamethasone.

Detailed description: 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 healing.

Eligibility criteria: Inclusion Criteria:

* Subject has intraabdominal disease either proven or strongly suspected to be ovarian or primary peritoneal cancer, and will be undergoing surgical debulking.
* Subject is not allergic to dexamethasone, and there is no obvious medical contraindication to dexamethasone.
* Subjects with diabetes requiring drug therapy are excluded.
* Subject is not currently receiving glucocorticoid therapy
* Nasal steroids (e.g. Flonase) are permitted
* Subject understands that this protocol does not have therapeutic intent
* Preoperative serum albumin at least 3.0 mg/dL
* Negative serum or urine pregnancy test in women of childbearing potential
* Signed informed consent

Exclusion Criteria:

* Males do not get ovarian cancer and therefore will not be included in this trial.
* Patients of all ethnic backgrounds are eligible and will be encouraged to enroll. However we do not expect differences based on ethnicity, and this small study will not therefore be powered to make conclusions about ethnic differences in induction of GR-regulated genes with dexamethasone.

Primary outcomes:
measure: Increase in SGK1 mRNA Expression Level
timeFrame: >= 30 min
measure: Increase in MKP1/DuSP1 mRNA Expression Level
timeFrame: >= 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: 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.
name: Gini Fleming, MD
role: STUDY_CHAIR
References:
citation: Melhem A, Yamada SD, Fleming GF, Delgado B, Brickley DR, Wu W, Kocherginsky M, Conzen SD. Administration of glucocorticoids to ovarian cancer patients is associated with expression of the anti-apoptotic genes SGK1 and MKP1/DUSP1 in ovarian tissues. Clin Cancer Res. 2009 May 1;15(9):3196-204. doi: 10.1158/1078-0432.CCR-08-2131. Epub 2009 Apr 21.