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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Sponsored by
New Mexico Cancer Care Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fallopian Tube Cancer focused on measuring Ketorolac, Bioavailability, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of New Mexico Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketorolac

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2012
Last Updated
February 25, 2020
Sponsor
New Mexico Cancer Care Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT01670799
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Keywords
Ketorolac, Bioavailability, Pain

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Ketorolac tromethamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure levels of Ketorolac in peritoneal cavity
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Measure effect of IV Ketorolac on ovarian cancer cell adhesion and migration
Description
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
Time Frame
Up to 48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Muller, MD
Organizational Affiliation
UNM Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.unm.edu
Description
UNM Cancer Center website
URL
http://www.nmcca.org
Description
New Mexico Cancer Care Alliance website

Learn more about this trial

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

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