Tumor Gene Expression in Women With Ovarian Cancer

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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.