Brief Title
Availability & Effect of Post-OP Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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
Brief Summary
The purpose of this study is to evaluate the anti-cancer effect of a pain medication called ketorolac (Toradol) on ovarian cancer cells in the abdominal (peritoneal) cavity after surgery for ovarian, fallopian tube or primary peritoneal cancer.
Detailed Description
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 Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Measure levels of Ketorolac in peritoneal cavity
Secondary Outcome
Measure effect of IV Ketorolac on ovarian cancer cell adhesion and migration
Condition
Fallopian Tube Cancer
Intervention
Ketorolac
Study Arms / Comparison Groups
Ketorolac
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
29
Start Date
March 2012
Completion Date
December 2015
Primary Completion Date
December 2015
Eligibility Criteria
Inclusion Criteria: (PRE-OPERATIVE [OP]) - Patients must be suspected of having a diagnosis of ovarian, fallopian tube or primary peritoneal cancer with a planned cytoreductive surgery - Borderline ovarian cancer with ascites - Eastern Cooperative Oncology Group (ECOG)/Zubrod/ Southwest Oncology Group (SWOG) performance status < 2 (Karnofsky performance status >= 70%) - Ability to provide informed consent - Absolute neutrophil count > 1000/uL - Platelet count > 100'000/uL - Serum creatinine =< 1.5 x upper limit of normal (ULN) - Bilirubin =< 1.5 x normal - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels =< 2 x ULN - No known bleeding disorders - No known sensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs) - No active peptic ulcer disease - No active bleeding - SECONDARY ELIGIBILITY - Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer on frozen section diagnosis - Placement of an intraperitoneal port at the time of surgery for anticipated use for adjuvant chemotherapy or management of post-operative ascites - If epidural catheter was used - the catheter must be removed prior to treatment - No active bleeding Exclusion Criteria: - Non-epithelial ovarian cancer or metastatic cancer to the ovaries - Borderline ovarian cancer without ascites - Presumed early stage ovarian cancer - No clinical indication for a peritoneal port - Active use of an epidural catheter - Uncontrolled or unstable medical conditions - Off study use of ketorolac or other NSAIDs prior to study administration - Active bleeding or high risk of bleeding - Active therapeutic anticoagulation - Known hypersensitivity to NSAIDs - Chronic or acute renal insufficiency as defined by a preoperative serum creatinine greater than 1.5mg/dL or creatinine clearance of < 60 ml/min - Any co-morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Carolyn Muller, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01670799
Organization ID
INST 1115
Secondary IDs
NCI-2012-00917
Responsible Party
Sponsor
Study Sponsor
New Mexico Cancer Care Alliance
Study Sponsor
Carolyn Muller, MD, Principal Investigator, UNM Cancer Center
Verification Date
February 2020