Tumor Gene Expression in Women With Ovarian Cancer

Phase 4

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Placebo; Drug: Dexamethasone

• Registration Number: NCT00817479
• Lead Sponsor: University of Chicago

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2016-06
• Results First Submitted: 2016-06-02
• Results First Submitted QC: 2016-06-02
• Last Update Submitted: 2016-06-02
• Results First Posted: 2016-07-13
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo [Saline]	Placebo	Saline
Dexamethasone	Dexamethasone	20 mg of dexamethasone

Primary Outcome Measures

Name	Time	Method
Increase in SGK1 mRNA Expression Level	>= 30 min	Increase in SGK1 mRNA expression level is calculated as fold change = post / pre
Increase in MKP1/DuSP1 mRNA Expression Level	>= 30 min	Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States