Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer
18 Years
59 Years
Female
Ovarian Cancer
Trial Information
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
healing.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
10 DAYS
Safety Issue:
No
Principal Investigator
Gini Fleming, MD
Investigator Role:
Study Chair
Investigator 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.
Authority:
United States: Institutional Review Board
Study ID:
11892A
NCT ID:
NCT00817479
Start Date:
January 2003
Completion Date:
February 2015
Related Keywords:
- Ovarian Cancer
- Subject has intraabdominal disease either proven or strongly
- suspected to be ovarian or primary peritoneal cancer
- Ovarian Neoplasms
Name | Location |
|---|---|
| The University of Chicago | Chicago, Illinois 60637 |
