The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs.
This is an open-label, randomized phase II study to investigate the feasibility of alternating cycles of treatment with sunitinib and everolimus compared to sequential treatment of sunitinib followed by everolimus. The study population consists of adult patients (over 18 years old) with clear cell mRCC (Metastatic Renal Cell Cancer) who have not received prior therapy for their metastatic disease. The purpose of the study is to determine the progression free survival, feasibility and safety profile of the experimental arm compared to standard of care. In the experimental arm alternating treatment will consist of repeating cycles of 24 weeks of treatment consisting of 12 weeks of sunitinib 4weeks on 2 weeks off, 50 mg pd followed by 12 weeks of everolimus 10 mg per day 11 weeks on 1 week off in patients with metastatic clear cell renal cancer. The comparative arm will be the standard regimen of sunitinib (50 mg pd 4/2) until progression, followed thereafter by everolimus (10 mg per day continuously, 11/1) until progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
50 mg pd
10 mg pd
Hopital Bordeaux University
Bordeaux, France
ALEXANDRA General Hospital of Athens
Athens, Greece
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Central de Asturias
Progression-free survival (PFS) rate 1 year
Time frame: 12 months
PFS of rotational arm versus PFS of the 2 lines in control arm
Time frame: From date of randomization until the date of first documented progression assesed up to 30 months
Overall Survival
Time frame: From the date of the tratment start to the date of death or the last contact for alived patients at the momment of data censored. Assesed up to 30 months
Safety Profile
Time frame: From the first treatment dose until 28 days after study treatment discontinuation. Assesed up to 30 months
Objective tumor response rate per arm
Time frame: From the date of first tumor response to the date of progression or start date of other cancer therapy. Assesed up to 30 months
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Oviedo, Principality of Asturias, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Clara Campal. Hospital Sanchinarro
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital General Universitario de Valencia
Valencia, Spain