Phase II study for the evaluation of neoadjuvant treatment with cabozantinib prior to cytoreductive nephrectomy in patients with locally advanced or metastatic renal cell carcinoma - CABOPRE

Fundación ONCOSUR0 sites50 target enrollmentAugust 2, 2018

Overview

No summary available.

Registry

who.int

Start Date

August 2, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Fundación ONCOSUR

•Patients must meet the following inclusion criteria:
•1\. Patients with locally advanced or metastatic renal cell carcinoma with a clear cell component confirmed histologically by biopsy.
•2\. Patients eligible for CN according to their surgical risk established in routine clinical practice at the center.
•3\. Age \= 18 years.
•4\. Patients with an ECOG performance status of between 0 and 1\.
•5\. Patients with appropriate organ and bone marrow function within 4 weeks prior to starting treatment with cabozantinib:
•oLeukocyte count \> 4,000 cells/µL
•oHemoglobin \> 9 g/dL
•oPlatelet count \> 100,000/mm3
•oSerum creatinine \< 2\.0 mg/dL or serum creatinine clearance \> 30 mL/min (according to the Cockcroft\-Gault formula (Cockcroft and Gault 1976\).

•1\. Patients with a second active malignant tumor.
•2\. Patients with tumors treated in the last 2 years.
•3\. Pregnant or breast\-feeding women.
•4\. Women of child\-bearing potential who do not agree to use a contraceptive method during treatment. Women participating in the study should have undergone surgical sterilization, be post\-menopausal, or agree to use a highly effective contraceptive method (in accordance with CTFG criteria) during the treatment period. Both patients of both sexes and their partners must use effective contraception during treatment and, at least, up to four months after completing treatment. Since oral contraceptives can not possibly be considered effective contraceptive methods, they should be used in conjunction with another method, such as a barrier method.
•5\. Fertile men who do not agree to use a contraceptive method during treatment. Male participants in the study should have undergone surgical sterilization, or agree to use a highly effective contraceptive method (in accordance with CTFG criteria) during the treatment period.
•6\. Patients with gastrointestinal disorders, including:
•oInability to take oral medication.
•oNeed for parenteral nutrition.
•oPrior surgical procedures affecting absorption.
•oActive gastrointestinal bleeding.