Tumor Gene Expression in Women With Ovarian Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone

20 mg of dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

20 MG OF DEXAMETHASONE OR PLACEBO

Placebo [Saline]

Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo saline

Interventions

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Dexamethasone

20 MG OF DEXAMETHASONE OR PLACEBO

Intervention Type DRUG

Placebo

Placebo saline

Intervention Type DRUG

Other Intervention Names

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Saline Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gini Fleming, MD

Role: STUDY_CHAIR

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.