Combination of Temsirolimus and Bevacizumab in Patient With Metastatic Renal Cell Carcinoma

Sponsor
Centre Leon Berard
Study ID
NCT00619268
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Temsirolimus — DRUG
    25 mg once per week administered intravenously
  • Bevacizumab — DRUG
    10 mg/kg \* 1 time /2 weeks administered intravenously
  • Sunitinib — DRUG
    50 mg administered orally once daily in 6 weeks cycles :4 weeks of treatment followed by 2 weeks off
  • Interferon alpha-2a — DRUG
    Administered subcutaneously as 9 MU three times per week

Study Details

The TORAVA trial is designed to evaluate the progression-free rate at 48 weeks of a combination of Torisel® and Avastin® given at first-line treatment in patients with metastatic renal cancer. Eligible patients will be randomly assigned, in a 2:1:1 ratio, to either Avastin® + Torisel®, or Sutent® or IFN+Avastin®.

Key Dates

First listed
Feb 20, 2008
Start date
Feb 29, 2008
Status verified
Feb 2013
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
  • Active Comparator: B
  • Active Comparator: C

Primary Outcome Measure

progression-free rate [ Time Frame: at 48 weeks post-treatment ]

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