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

NCT01670799 | Completed Early Phase 1 DMC

• 2 other identifiers: INST 1115NCI-2012-00917
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

Ketorolac; Bioavailability; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure effect of IV Ketorolac on ovarian cancer cell adhesion and migration

  Up to 48 hours

Study Arms (1)

Ketorolac

EXPERIMENTAL

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.

Drug: Ketorolac

Interventions

Ketorolac 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.

Also known as: Ketorolac tromethamine

Ketorolac

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead

Study Sites (1)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Related Links

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

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Pain

Interventions

Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Carolyn Muller, MD

  UNM Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2012
• First Posted: August 22, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

US (1)