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Tumor Gene Expression in Women With Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gini Fleming, University of Chicago
ClinicalTrials.gov Identifier:
NCT00817479
First received: January 5, 2009
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Ovarian Cancer
 Drug: Dexamethasone
Drug: Placebo
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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. [ Time Frame: 10 DAYS ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2003
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone
20 mg of dexamethaseone
 Drug: Dexamethasone
20 MG OF DEXAMETHASONE OR PLACEBO
Other Name: Dexamethasone
Placebo Comparator: Arm 2 Drug: Placebo
Placebo saline
Other Name: Saline Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817479

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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

No publications provided

Responsible Party: Gini Fleming, Professor of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT00817479     History of Changes
Other Study ID Numbers: 11892A
Study First Received: January 5, 2009
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

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:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013