Overview

Everolimus in Patients With Metastatic Renal Cell Carcinoma Following Progression on Prior Bevacizumab Treatment

Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
0
Participant gender:
All
Summary
An estimated 10,000 metastatic renal cell carcinoma (RCC) patients receive first-line therapy in the Russian Federation. Bevacizumab (Avastin) in combination with interferon-alpha (IFN) is a recommended first-line treatment for metastatic RCC according to clinical recommendations of Russian Ministry of Health from 15.07.2010. Two randomized phase III trials (AVOREN, CALGB) showed that 50% of patients will progress on bevacizumab plus IFN within 8.5 - 10.2 months and will need sequential therapy. Everolimus (Afinitor) is a single agent which was evaluated and demonstrated efficacy in randomized phase III study (RECORD-1) in metastatic RCC patients after failure of targeted therapy. However, in this trial everolimus was compared with placebo for the treatment of patients whose disease had progressed on treatment with sunitinib or sorafenib (n=227). Only 9% (n=24) of patients received bevacizumab. Thus, efficacy data of everolimus in patients with disease progression on first-line bevacizumab is limited. Evaluating the effectiveness of everolimus in metastatic RCC patients with failure on bevacizumab with/without interferon alpha has a scientific and practical sense, and it is important for Russian Federation.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kidney Cancer Research Bureau
Treatments:
Bevacizumab
Everolimus
Sirolimus
Criteria
Inclusion Criteria:

- Histologically proven renal cell carcinoma

- CT-confirmed measurable disease

- Disease progression after bevacizumab +/- IFN

- Favorable/intermediate prognosis according to MSKCC

- Nephrectomy

- No contradictions to everolimus

- Age 18 or older

- Written informed consent

Exclusion criteria

- prior TKI's or mTOR inhibitor

- pregnant or nursing

- history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or
other severe cardiovascular disease (i.e., New York Heart Association class III or IV)

- CNS metastases by neurologic exam and/or MRI

- local and/or systemic infections requiring antibiotics within 28 days prior to study
entry

- other malignancy