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

Completed · Early Phase 1

Conditions studied: Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

In brief

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.

Key facts

Study ID

NCT01670799

Run by

New Mexico Cancer Research Alliance

People needed

29

Starts

2012-03-01

Expected to finish

2015-12-01

Last updated by the study team

2020-02-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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
• 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

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

Where it is running

• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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