Tumor Gene Expression in Women With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817479
• Other study ID #: 11892A
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2009
• Last updated: November 17, 2014
• Start date: January 2003
• Est. completion date: January 2013

Study information

• Verified date: November 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Dexamethasone
20 MG OF DEXAMETHASONE OR PLACEBO
• Placebo
Placebo saline

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		10 DAYS	No