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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01670799
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : February 27, 2020
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Drug: Ketorolac Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : March 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: 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.

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.
Other Name: Ketorolac tromethamine

Primary Outcome Measures :
  1. Measure levels of Ketorolac in peritoneal cavity [ Time Frame: 24 hours ]
    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 :
  1. Measure effect of IV Ketorolac on ovarian cancer cell adhesion and migration [ Time Frame: Up to 48 hours ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01670799

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United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
New Mexico Cancer Care Alliance
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Principal Investigator: Carolyn Muller, MD UNM Cancer Center
  Study Documents (Full-Text)

Documents provided by New Mexico Cancer Care Alliance:
Additional Information:
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Responsible Party: New Mexico Cancer Care Alliance Identifier: NCT01670799    
Other Study ID Numbers: INST 1115
NCI-2012-00917 ( Registry Identifier: NCI CTRP )
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Keywords provided by New Mexico Cancer Care Alliance:
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action