Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Renal Cell Carcinoma

Sponsor
Massachusetts General Hospital
Study ID
NCT00556205
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sunitinib — DRUG
    Sunitinib orally once daily
  • Bevacizumab — DRUG
    Intravenously every 14 days

Study Details

The purpose of this research study is to further define an effective strategy for people with renal cell carcinoma and to learn the safety and effectiveness of two different types of sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and bevacizumab. Sunitinib is an FDA approved drug and is currently one of the standard treatments for advanced renal cell carcinoma. However, some people who receive this treatment do not respond to treatment or they stop responding to treatment. Bevacizumab is an FDA approved drug used for the treatment of several cancers however, is not yet approved for use in renal cell carcinoma.

Key Dates

First listed
Nov 9, 2007
Start date
Sep 30, 2009
Status verified
Mar 2016
Primary completion
Sep 30, 2009
Completion
Sep 30, 2009

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Bevacizumab monotherapy 10 mg/kg IV q2 weeks
  • Active Comparator: 2
    Combination Sunitinib \& Bevacizumab Bevacizumab 10 mg/kg IV q2 weeks Sunitinib 50 mg PO QD on 4/2 schedule

Primary Outcome Measure

To determine the time to tumor progression (TTP) in this patient population treated with bevacizumab or combination of sunitinib and bevacizumab. [ Time Frame: Until tumor progression ]

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