Clinical Trial: High-dose Bevacizumab in Advanced Renal Carcinoma Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Trial of High-Dose Bevacizumab in the Treatment of Patients With Advanced Clear Cell Renal Carcinoma

Brief Summary: This trial will examine the effectiveness and the side effects of 2 higher dosing schedules of bevacizumab in patients that have advanced clear cell renal carcinoma.

Detailed Summary:

Bevacizumab is considered a targeted drug. Targeted drugs act on specific receptors on a cell. Bevacizumab blocks receptors that help cancer cells develop blood supplies so that the cancer can grow. These specific receptors are found in greater numbers in kidney cancer. In that regard bevacizumab will be tested in 2 doses that are higher than non-kidney cancer treatments with bevacizumab.

One group of patients will receive bevacizumab at 15 mg per kg by vein every 2 weeks. A total of 75 patients will be treated with this dose.

If this dose is well tolerated a second group of patients will receive bevacizumab at 15mg per kg by vein weekly.


Sponsor: SCRI Development Innovations, LLC

Current Primary Outcome: Progression-free Survival [ Time Frame: 18 months (expected) ]

Progression-free survival is measured from Day 1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions


Original Primary Outcome:

  • Effectiveness of the treatment will be measured by periodic tests/scans
  • Side effects of treatment will be evaluated at each patient visit


Current Secondary Outcome:

  • Overall Survival (OS) [ Time Frame: 18 months ]
    Measured from date of study entry to date of death due to any cause.
  • Objective Response Rate [ Time Frame: 18 months ]
    The number of patients with observed complete response [CR] or partial response [PR]. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR
  • Overall Tolerability and Toxicity of High-dose Bevacizumab [ Time Frame: 18 months ]
    Number of patients treated with high-dose bevacizumab experiencing Grade 3/4, treatment-related toxicities


Original Secondary Outcome: Define overall tolerability and toxicity of the high-dose bevacizumab regimen

Information By: SCRI Development Innovations, LLC

Dates:
Date Received: April 3, 2007
Date Started: February 2007
Date Completion:
Last Updated: December 12, 2014
Last Verified: December 2014