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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Mexico Cancer Care Alliance
• Treatments: Ketorolac; Ketorolac Tromethamine

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