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

NCT ID: NCT01670799

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-12-31

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ketorolac

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.

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ketorolac tromethamine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

New Mexico Cancer Research Alliance

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolyn Muller, MD

Role: PRINCIPAL_INVESTIGATOR

UNM Cancer Center

Locations

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://cancer.unm.edu

UNM Cancer Center website

http://www.nmcca.org

New Mexico Cancer Care Alliance website

Other Identifiers

NCI-2012-00917

Identifier Type: REGISTRY

Identifier Source: secondary_id

INST 1115

Identifier Type: -

Identifier Source: org_study_id