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

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

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.

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Measure levels of Ketorolac in peritoneal cavity

Secondary Outcome

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

Condition

Fallopian Tube Cancer

Intervention

Ketorolac

Study Arms / Comparison Groups

 Ketorolac

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

March 2012

Completion Date

December 2015

Primary Completion Date

December 2015

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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Carolyn Muller, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01670799

Organization ID

INST 1115

Secondary IDs

NCI-2012-00917

Responsible Party

Sponsor

Study Sponsor

New Mexico Cancer Care Alliance

Study Sponsor

Carolyn Muller, MD, Principal Investigator, UNM Cancer Center

Verification Date

February 2020