Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT00113217|
Recruitment Status : Completed
First Posted : June 7, 2005
Results First Posted : January 14, 2014
Last Update Posted : January 14, 2014
The goal of this clinical research study is to learn if bevacizumab (Avastin®) can control metastatic renal cell carcinoma (RCC). The safety of the treatment will also be studied.
- To assess the efficacy of neoadjuvant therapy of bevacizumab by evaluating time to progression.
- Toxicities of therapy with bevacizumab in RCC.
- Response rate
- Duration of response
- Overall Survival
- Serum and plasma levels of matrix metalloproteinase 9 (MMP-9) and MMP-2, Interleukin 6 (IL-6), vascular endothelial growth factor (VEGF), and Basic Fibroblast Growth Factor (bFGF) pre- and post- therapy (optional studies).
- Tissue expression of Phospho-epidermal growth factor receptor (EGFR), VEGF, vessel count CD31/34, AKT and Phospho-AKT, mitogen-activated protein kinase (MAPK), transforming growth factor-alpha (TGF-alpha), phospho-STAT3 and TUNEL post therapy (optional studies).
- complementary DNA (cDNA) microarray analysis of tissue post-therapy (optional studies).
- Tissue expression of tumor infiltrating lymphocytes and tumor antigens
- Pathological response rate in primary tumor.
- To evaluate the Single Nucleotide Polymorphisms (SNP) patterns in nephrectomy specimens from patients participating in the study.
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Kidney Cancer||Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Neoadjuvant Clinical Trial to Evaluate the Efficacy of Recombinant Humanized Monoclonal Anti-VEGF Antibody rhuMab VEGF (Bevacizumab) for Renal Cell Carcinoma|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
10 mg/kg IV on day 1 of each 14-day cycle.
Other Name: Avastin
- Progression Free Survival (PFS) [ Time Frame: Up to 3 years (or until disease progression) ]Time to progression calculated from the start of the study drug to the first evidence of disease progression. Time to progression reported as PFS measured in months. Progression (or progressive disease) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 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.
- Safety of Treatment [ Time Frame: Following 56 days treatment ]Safety measured by participant toxicities in therapy with bevacizumab for Renal Cell Carcinoma (RCC).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113217
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eric Jonasch, MD||M.D. Anderson Cancer Center|