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Cabozantinib in Treating Patients with Locally Advanced Non-metastatic Kidney Cancer

Status
Active
Cancer Type
Kidney Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04022343
Protocol IDs
Winship4643-19 (primary)
NCI-2019-02253
IRB00110583
Study Sponsor
Emory University Hospital/Winship Cancer Institute

Summary

This phase II trial studies how well cabozantinib works in treating patients with kidney cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) and not to other places in the body (non-metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This study is being done to see if cabozantinib is effective in kidney cancer before surgery.

Objectives

PRIMARY OBJECTIVE:
I. To assess the objective response rate (complete and partial responses), following the administration of cabozantinib S-malate (cabozantinib) for 12 weeks in patients with locally advanced biopsy-proven non-metastatic clear cell renal cell carcinoma (ccRCC) prior to undergoing surgery.

SECONDARY OBJECTIVES:
I. To assess the safety, and tolerability of neoadjuvant cabozantinib.
II. To determine the clinical outcome (disease-free survival [DFS], overall survival [OS]) of patients with non-metastatic ccRCC who treated with neoadjuvant cabozantinib.
III. To evaluate the surgery related outcomes.
IV. To evaluate correlative studies, including biomarkers, quality of life, and frailty/sarcopenia assessment of patients with non-metastatic ccRCC who are treated with neoadjuvant cabozantinib.

OUTLINE:
Patients receive cabozantinib S-malate orally (PO) once daily (QD) for 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Eligibility

  1. Patients with renal mass consistent with a clinical stage >= T3Nx or TanyN+ or deemed unresectable by surgeon
  2. Renal cell carcinoma with clear cell component on pre-treatment biopsy of the primary tumor
  3. Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  4. Absolute neutrophil count (ANC) >= 1500/mm^3 (>= 1.5 GI/L) without granulocyte colony-stimulating factor support (within 14 days before first dose of study treatment)
  5. White blood cell count >= 2500/mm^3 (>= 2.5 GI/L) (within 14 days before first dose of study treatment)
  6. Platelets >= 100,000/mm^3 (>= 100 GI/L) without transfusion (within 14 days before first dose of study treatment)
  7. Hemoglobin >= 9 g/dL (within 14 days before first dose of study treatment)
  8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN) (within 14 days before first dose of study treatment)
  9. Alkaline phosphatase (ALP) =< 3 x upper limit of normal (ULN). ALP =< 5 x ULN with documented bone metastases (within 14 days before first dose of study treatment)
  10. Total bilirubin =< 1.5 x ULN (for subjects with Gilbert’s disease =< 3 x ULN) (within 14 days before first dose of study treatment)
  11. Serum albumin >= 2.8 g/dl (within 14 days before first dose of study treatment)
  12. Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 40 mL/min (>= 0.67 mL/sec) using the Cockcroft-Gault equation (within 14 days before first dose of study treatment)
  13. Urine protein/creatinine ratio (UPCR) =< 1 mg/mg (=< 113.2 mg/mmol) (within 14 days before first dose of study treatment)
  14. No hormonal therapy, chemotherapy, immunotherapy, or any other systemic therapy for a malignancy, in the 5 years prior to current study enrollment
  15. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment
  16. Female subjects of childbearing potential must not be pregnant at screening. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons
  17. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document

Treatment Sites in Georgia

Emory University Hospital - Atlanta


1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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