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
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Measure levels of Ketorolac in peritoneal cavity
Outcome Description:
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.
Outcome Time Frame:
24 hours
Safety Issue:
No
Principal Investigator
Carolyn Muller, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UNM Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
INST 1115
NCT ID:
NCT01670799
Start Date:
March 2012
Completion Date:
December 2014
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Peritoneal Cavity Cancer
- Ketorolac
- Bioavailability
- Pain
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
