Study on Cabozantinib Before Surgery for Locally Advanced Kidney Cancer

Sponsor: Emory University

Sponsor score: 40

ClinicalTrials ID:NCT04022343

Provider View

This clinical trial is testing how well the drug cabozantinib works in shrinking kidney tumors before surgery. Cabozantinib may help stop tumor growth by blocking certain enzymes needed for cancer cells to grow.

Patient Parameters

Program Overview

The purpose of this study is to see if cabozantinib can effectively reduce the size of kidney tumors in patients with locally advanced kidney cancer before they undergo surgery. Cabozantinib works by blocking enzymes that help cancer cells grow.

Description

The main goal of this study is to see how many patients experience a reduction in tumor size after taking cabozantinib for 12 weeks before surgery. Researchers will also look at the safety and side effects of cabozantinib, as well as how it affects patients' survival without the disease returning and overall survival. Additionally, the study will evaluate surgery outcomes and other factors like quality of life and physical health.

Participants will take cabozantinib by mouth once a day for 12 weeks, as long as the cancer does not progress or cause unacceptable side effects. After finishing the treatment, patients will have follow-up visits every 3 months to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Have a kidney tumor that is at least stage T3Nx or TanyN+ or considered not removable by a surgeon.
  • Have clear cell renal cell carcinoma confirmed by a biopsy.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and bone marrow function based on specific blood test results.
  • Not have received any hormonal, chemotherapy, immunotherapy, or other systemic cancer treatments in the past 5 years.
  • Agree to use effective contraception during the study and for 4 months after the last dose if sexually active.
  • Women must not be pregnant and must have a negative pregnancy test before starting the study.
  • Be able to understand and agree to the study requirements and sign an informed consent form.

Exclusion Criteria

  • Have evidence of cancer spread to other parts of the body.
  • Have received any previous cancer treatment for kidney cancer.
  • Have known brain metastases or disease affecting the brain.
  • Be taking certain blood thinners or platelet inhibitors, except for low-dose aspirin or specific low molecular weight heparins.
  • Have uncontrolled or significant health issues, such as severe heart problems, recent stroke, or serious gastrointestinal disorders.
  • Have had major surgery within 8 weeks before starting the study, unless fully healed.
  • Have a prolonged QT interval on an ECG test.
  • Be pregnant or breastfeeding.
  • Be unable to swallow tablets.
  • Have an allergy to the study drug.
  • Have another cancer diagnosis within the past 2 years, except for certain skin cancers or low-grade tumors.

Locations

FACILITYZIPCITYSTATE
Emory University Hospital/Winship Cancer Institute30322AtlantaGeorgia

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