Availability & Effect of Post-OP Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670799
• Other study ID #: INST 1115
• Secondary ID: NCI-2012-00917
• Status: Completed
• Phase: Early Phase 1
• Start date: March 2012
• Est. completion date: December 2015

Study information

• Verified date: February 2020
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cavity Cancer

Intervention

Drug:
• Ketorolac
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.

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure levels of Ketorolac in peritoneal cavity	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.	24 hours
Secondary	Measure effect of IV Ketorolac on ovarian cancer cell adhesion and migration	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	Up to 48 hours

External Links

•   New Mexico Cancer Care Alliance website
•   UNM Cancer Center website