Neoadjuvant Cabozantinib in Treating Patients With Locally Advanced Kidney Cancer (NCT04022343) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Cabozantinib in Treating Patients With Locally Advanced Kidney Cancer
United States22 participantsStarted 2019-08-06
Plain-language summary
This phase II clinical trial studies how well cabozantinib works in treating patients with kidney cancer before surgery. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with renal mass consistent with a clinical stage ≥ T3Nx or TanyN+ or deemed unresectable by surgeon.
* Renal cell carcinoma with clear cell component on pre-treatment biopsy of the primary tumor.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
* Patients must have adequate organ and marrow function, based upon meeting all of the following laboratory criteria within 14 days before first dose of study treatment:
* Absolute neutrophil count (ANC) ≥ 1500/mm³ (≥ 1.5 GI/L) without granulocyte colony-stimulating factor support.
* White blood cell count ≥ 2500/mm³ (≥ 2.5 GI/L).
* Platelets ≥ 100,000/mm³ (≥ 100 GI/L) without transfusion.
* Hemoglobin ≥ 9 g/dL.
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x upper limit of normal (ULN). ALP ≤ 5 x ULN with documented bone metastases.
* Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN).
* Serum albumin ≥ 2.8 g/dl.
* Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 mL/min (≥ 0.67 mL/sec) using the Cockcroft-Gault equation:
* Males: (140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)
* Females: \[(140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)\] × 0.85
* Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol).
* No hormonal therapy, chemotherapy, immunotherapy, or any other systemic therapy for a malignancy, in the 5 years prior t…