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Tumor Gene Expression in Women With Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00817479
Recruitment Status : Completed
First Posted : January 6, 2009
Results First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Dexamethasone Drug: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer
Study Start Date : January 2003
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dexamethasone
20 mg of dexamethasone
 Drug: Dexamethasone
20 MG OF DEXAMETHASONE OR PLACEBO
Placebo Comparator: Placebo [Saline]
Saline
 Drug: Placebo
Placebo saline
Other Name: Saline Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Increase in SGK1 mRNA Expression Level [ Time Frame: >= 30 min ]
    Increase in SGK1 mRNA expression level is calculated as fold change = post / pre

  2. Increase in MKP1/DuSP1 mRNA Expression Level [ Time Frame: >= 30 min ]
    Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817479


Locations
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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Study Chair: Gini Fleming, MD 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.
More Information
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Publications of Results:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00817479    
Other Study ID Numbers: 11892A
First Posted: January 6, 2009    Key Record Dates
Results First Posted: July 13, 2016
Last Update Posted: July 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Chicago:
Subject has intraabdominal disease either proven or strongly
suspected to be ovarian or primary peritoneal cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents