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Tumor Gene Expression in Women With Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00817479
First received: January 5, 2009
Last updated: November 17, 2014
Last verified: November 2014

January 5, 2009
November 17, 2014
January 2003
January 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00817479 on ClinicalTrials.gov Archive Site
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Tumor Gene Expression in Women With Ovarian Cancer
Tumor Gene Expression Before and After Intraoperative Dexamethasone in Women With Ovarian Cancer

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Ovarian Cancer
  • Drug: Dexamethasone
    20 MG OF DEXAMETHASONE OR PLACEBO
    Other Name: Dexamethasone
  • Drug: Placebo
    Placebo saline
    Other Name: Saline Placebo
  • Active Comparator: Dexamethasone
    20 mg of dexamethaseone
    Intervention: Drug: Dexamethasone
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00817479
11892A
Yes
University of Chicago
University of Chicago
Not Provided
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.
University of Chicago
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP