Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy

Conditions

• Clear Cell Renal Cell Carcinoma
• Recurrent Renal Cell Carcinoma
• Stage III Renal Cell Cancer AJCC v7
• Stage IV Renal Cell Cancer AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Everolimus — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies

Study Details

This randomized phase III trial studies giving everolimus together with bevacizumab to see how well it works compared to everolimus alone in treating patients with advanced kidney cancer that progressed after first-line therapy. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can interfere with tumor growth by blocking the ability of tumor cells to grow and spread. Everolimus and bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. It is not yet known whether giving everolimus together with bevacizumab is better than everolimus alone in treating patients with advanced kidney cancer that has progressed after first-line therapy.

Key Dates

First listed

Sep 9, 2010

Start date

Sep 15, 2010

Status verified

Mar 2019

Primary completion

Dec 15, 2017

Completion

Dec 16, 2017

Study Design

Enrollment

77 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (everolimus)
  Patients receive everolimus PO QD on days 1-28.
• Experimental: Arm II (everolimus with bevacizumab)
  Patients receive everolimus PO QD on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: The time from date of randomization to date of death due to any cause, assessed up to 5.5 years ]

Locations (524)

Find similar trials in Scottsdale, AZ

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