Ketorolac before Surgery for the Treatment of Stage I-II Non-small Cell Lung Cancer or Stage III Renal Cell Cancer

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT04495894
Trial Phases:	Phase I	Protocol IDs:	WINSHIP4977-20 (primary) NCI-2020-02709
Eligibility:	18 - 80 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04495894

Summary

This phase I trial studies the side effects of ketorolac before surgery in treating patients with stage I-II non-small cell lung cancer or stage III renal cell cancer. Surgical trauma increases the production of prostaglandins and thromboxanes, which have tumor-promoting and immunosuppressive activities and reduce the activity of natural killer cells, which impairs the ability of the immune system to keep cancer cells in check. However, if given just before tissue injury, non-steroidal anti-inflammatory drugs, such as ketorolac, may be able to block the production of prostaglandins/thromboxanes and boost the activity of natural killer cells, thereby decreasing the risk of cancer coming back.

Objectives

PRIMARY OBJECTIVE:
I. To test the safety of a single pre-incisional dose of 30 mg ketorolac in patients undergoing surgery for stage I/II non-small cell lung cancer (NSCLC) and stage III renal cell cancer (RCC), as these are the stages of cancer most likely to develop a recurrence while still noting a benefit from the ketorolac.

SECONDARY OBJECTIVE:
I. To evaluate blood and tissue samples pre- and post-operatively to assess the impact of ketorolac on key inflammatory biomarkers using a standard cytokine panel.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ketorolac intravenously (IV) prior to standard of care surgery. Patients additionally undergo blood sample collection throughout the study.

ARM II: Patients undergo standard of care surgery. Patients additionally undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up for 90 days and then renal cell cancer patients are followed up at 1 and 2 years post surgery.

Treatment Sites in Georgia

Emory Clinic
1365 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Emory University Hospital - Atlanta
1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.