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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). 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.
Primary Outcome
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.
Interventions
- DRUG Bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2005-02 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT00113217 record still lists
NCT00113217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which Bevacizumab is the first listed.
NCT00113217 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00113217's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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