Availability & Effect of Post-OP Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT01670799|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2012
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer||Drug: Ketorolac||Early Phase 1|
Ovarian cancer is the sixth most common cancer and the seventh most common cause of cancer deaths in women across the globe. The majority of women, nearly 70%, will present with advanced stage disease that heralds a poor prognosis.
Despite aggressive treatment that still favors initial debulking surgery followed by a platinum and taxane based chemotherapy regimen, most patients relapse after achieving a complete clinical response.
Our group has shown that the ketorolac can inhibit gene activity which inhibits cell proliferation and migration.Ketorolac will be used in this study with the goal of producing specific inhibition of cell adhesion and migration in ovarian cancer cells retrieved within the peritoneal cavity after cytoreductive surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial to Study the Availability and Effect of Post-OP IV Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer, Cells Retrieved From the Peritoneal Cavity|
|Study Start Date :||March 2012|
|Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2018|
U.S. FDA Resources
All patients will receive a single dose of IV ketorolac for pain management for the indication of post-operative pain control. Patients less than 65 years of age and in otherwise good health will receive a 30mg IV single dose. Patients 65 years of age or greater, or who have mild renal insufficiency or are of low weight (as per section 3.2) will receive a single 15 mg dose IV ketorolac.
In patients who have a clinical pain response and have no contraindications to multi-dose (every 6 hours over 24 hours), additional doses will be given per physician discretion based on clinical indication. Patients receiving 24 hour dosing will be eligible for sample time points after 24 hour dosing.
This is a pilot (feasibility) trial to determine the availability, concentration and racemic mixture of a clinically indicated pain medication, ketorolac, in the peritoneal cavity and the subsequent effect on free floating ovarian cancer cells in patients after cytoreductive surgery for ovarian cancer.
Other Name: Ketorolac tromethamine
- Measure levels of Ketorolac in peritoneal cavity [ Time Frame: 24 hours ]To determine the concentration of measurable levels of R and S- Ketorolac (and the percent racemic mixture) in the peritoneal cavity after intravenous (IV) administration in the post-operative patient after cytoreductive surgery.
- Measure effect of IV Ketorolac on ovarian cancer cell adhesion and migration [ Time Frame: Up to 48 hours ]The secondary endpoint of this study is to determine the effect of IV ketorolac on cell adhesion and migration of ovarian cancer cells retrieved from the peritoneal cavity after cytoreductive surgery
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): NCT01670799
|United States, New Mexico|
|University of New Mexico Cancer Center|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Carolyn Muller, MD||UNM Cancer Center|