Ovarian Cancer
Conditions
Keywords
Subject has intraabdominal disease either proven or strongly, suspected to be ovarian or primary peritoneal cancer
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.
Interventions
DRUGDexamethasone
20 MG OF DEXAMETHASONE OR PLACEBO
DRUGPlacebo
Placebo saline
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled between July 2003 and September 2007 through the Gynecologic Oncology Clinic at the University of Chicago subject to the inclusion and exclusion criteria described in the registration record.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo \[saline\] | 6 |
| Dexamethasone 20 mg dexamethasone IV push | 14 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Dexamethasone | Total |
|---|---|---|---|
| Age, Continuous | 61 years | 53.5 years | 56 years |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 14 |
| serious Total, serious adverse events | 0 / 6 | 0 / 14 |
Outcome results
Primary
Increase in MKP1/DuSP1 mRNA Expression Level
Increase in MKP1/DuSP1 mRNA expression level is calculated as fold change = post / pre
Time frame: >= 30 min
Population: Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Increase in MKP1/DuSP1 mRNA Expression Level | 1.1 fold change | Standard Error 0.4 |
| Dexamethasone | Increase in MKP1/DuSP1 mRNA Expression Level | 8.2 fold change | Standard Error 2.9 |
Primary
Increase in SGK1 mRNA Expression Level
Increase in SGK1 mRNA expression level is calculated as fold change = post / pre
Time frame: >= 30 min
Population: Eighteen of the 20 randomized patients received treatment. Eight of the treated patients were unevaluable because there was not enough tissue available during surgery for experimental studies; the remaining 10 patients had adequate tissue samples at baseline and at least at 30 minutes following dexamethasone/normal saline administration.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Increase in SGK1 mRNA Expression Level | 1.5 fold change | Standard Error 0.4 |
| Dexamethasone | Increase in SGK1 mRNA Expression Level | 6.1 fold change | Standard Error 2.6 |