Neoadjuvant Cabozantinib in Treating Patients With Locally Advanced Kidney Cancer

  • STATUS
    Recruiting
  • days left to enroll
    19
  • participants needed
    17
  • sponsor
    Emory University
Updated on 26 January 2021
cancer
systemic therapy
carcinoma
gilbert's syndrome
metastasis
neutrophil count
cabozantinib
hormone therapy
tumor cells
primary tumor
bone metastases
ovarian suppression
kidney cancer

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.

Description

PRIMARY OBJECTIVE:

I. To assess the objective response rate (complete and partial responses), following the administration of 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 treated with neoadjuvant cabozantinib.

OUTLINE

Patients receive cabozantinib 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.

Details
Condition Adenocarcinoma, Malignant neoplasm of kidney, Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Kidney Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, clear cell renal cell carcinoma
Treatment Cabozantinib
Clinical Study IdentifierNCT04022343
SponsorEmory University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Renal Cell Cancer or Kidney Cancer or Malignant neoplasm of kidney or Malignant Adenoma or Stage III Renal Cell Cancer AJCC v8 or Renal Cancer or Aden...?
Do you have any of these conditions: Renal Cell Carcinoma or Renal Cell Cancer or Renal Cancer or clear cell renal cell carcinoma or Stage III Renal Cell Cancer AJCC v8 or Adenocarcinoma ...?
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/mm ( 1.5 GI/L) without granulocyte colony-stimulating factor support
White blood cell count 2500/mm ( 2.5 GI/L)
Platelets 100,000/mm ( 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 to current study enrollment
Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, 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
Female subjects of childbearing potential must not be pregnant at screening. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (ie, 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
Capable of understanding and complying with the protocol requirements and must have signed the informed consent document

Exclusion Criteria

Evidence of metastatic disease on pre-treatment imaging
The subject has received of any type of cytotoxic, biologic or other systemic anticancer therapy for kidney cancer
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
Known brain metastases or cranial epidural disease
Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel). Allowed anticoagulants are the following
Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted
Low-dose low molecular weight heparins (LMWH) are permitted
Anticoagulation with therapeutic doses of LMWH is allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test 1.3 the laboratory ULN within 14 days before the first dose of study treatment
The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions
Cardiovascular disorders
Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias
Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment
Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before first dose
Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation
The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, active inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction
Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose
Clinically significant hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose
Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation
Other clinically significant disorders that would preclude safe study participation
Serious non-healing wound/ulcer/bone fracture
Uncompensated/symptomatic hypothyroidism
Moderate to severe hepatic impairment (Child-Pugh B or C)
Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
Prolongation of the QT corrected for HR using Fridericia's method (QTcF) interval defined as > 500 msec per electrocardiogram (ECG) within 28 days before first dose of study treatment. Note: If a single ECG shows a QTcF with an absolute value > 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility
Pregnant or lactating females
Inability to swallow tablets
Previously identified allergy or hypersensitivity to components of the study treatment formulations
Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy. Patients with Gleason 6 (3+3) prostate cancer with previous treatment or on active surveillance may also be allowed on protocol
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