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NCT00113217 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell Carcinoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT00113217: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00113217 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00113217, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
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. Objectives: Primary: 1. To assess the efficacy of neoadjuvant therapy of bevacizumab by evaluating time to progression. 2. Toxicities of therapy with bevacizumab in RCC. Secondary: Clinical: 1. Response rate 2. Duration of response 3. Overall Survival Preclinical: 1. 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). 2. 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). 3. complementary DNA (cDNA) microarray analysis of tissue post-therapy (optional studies). 4. Tissue expression of tumor infiltrating lymphocytes and tumor antigens 5. Pathological response rate in primary tumor. 6. To evaluate the Single Nucleotide Polymorphisms (SNP) patterns in nephrectomy specimens from patients participating in the study.
Interventions
- DRUG Bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2005-02 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00113217
The ClinicalTrials.gov registry entry for NCT00113217 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bevacizumab is the first listed.
NCT00113217 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00113217 about?
NCT00113217 is a clinical study titled "Neoadjuvant Clinical Trial to Evaluate the Efficacy of Bevacizumab for Renal Cell Carcinoma". 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. Objectives: Primary: 1. To assess the efficacy of neoadjuvant therapy of bevacizumab by evaluating time to progressio...
What is the current status of trial NCT00113217?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2005-02. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00113217?
The interventions under investigation include: Bevacizumab (DRUG).
Who is sponsoring clinical trial NCT00113217?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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