Clinical trial NCT01670799: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Keywords: Ketorolac
Bioavailability
Pain
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Measure levels of Ketorolac in peritoneal cavity
timeFrame: 24 hours
Secondary outcomes:
measure: Measure effect of IV Ketorolac on ovarian cancer cell adhesion and migration
timeFrame: Up to 48 hours
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
Study officials:
affiliation: UNM Cancer Center
name: Carolyn Muller, MD
role: PRINCIPAL_INVESTIGATOR
References: