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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by New Mexico Cancer Care Alliance
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01670799
First received: August 17, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: Ketorolac
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Measure levels of Ketorolac in peritoneal cavity [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 48 hours ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670799

Locations
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Valerie Parks, RN    505-925-0390    vparks@salud.unm.edu   
Principal Investigator: Carolyn Muller, MD         
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Carolyn Muller, MD UNM Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01670799     History of Changes
Other Study ID Numbers: INST 1115, NCI-2012-00917
Study First Received: August 17, 2012
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration
United States: University of New Mexico Data Safety and Monitoring Committee (DSMC)

Keywords provided by New Mexico Cancer Care Alliance:
Ketorolac
Bioavailability
Pain

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014