Ketorolac before Surgery for the Treatment of Stage I-II Non-small Cell Lung Cancer or Stage III Renal Cell Cancer
18 - 80 Years, Male and Female
WINSHIP4977-20 (primary)
NCI-2020-02709
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.
ARM II: Patients undergo standard of care surgery.
After completion of study treatment, patients are followed up for 90 days and then at 1 and 2 years post surgery.
Eligibility
- Pathology-proven or suspected stage 1 or 2 NSCLC and stage 3 T3N0 RCC, that require surgical resection as the treatment of choice
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Ability to understand and the willingness to sign an informed written consent
- Age >= 18 years and =< 80 years
Treatment Sites in Georgia
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