Clinical Trial: Bevacizumab With or Without TRC105 in Treating Patients With Metastatic Kidney Cancer
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase II Study of Bevacizumab Alone or in Combination With TRC105 for Advanced Renal Cell Cancer
Brief Summary: This randomized phase II trial studies how well bevacizumab with or without anti-endoglin monoclonal antibody TRC105 (TRC105) works in treating patients with kidney cancer that has spread to other parts of the body (metastatic). Monoclonal antibodies, such as bevacizumab and anti-endoglin monoclonal antibody TRC105, may block tumor growth in different ways by targeting certain cells.
Detailed Summary:
PRIMARY OBJECTIVES:
I. To compare the progression-free survival at 12 and 24 weeks for bevacizumab alone or in combination with TRC105 (anti-endoglin monoclonal antibody TRC105).
SECONDARY OBJECTIVES:
I. Toxicity and Response Evaluation Criteria in Solid Tumors (RECIST) response rate for the combination compared to single agent bevacizumab.
TERTIARY OBJECTIVES:
I. To evaluate tumor tissue expression of endoglin (CD105), transforming growth factor, beta receptor II (TGFBR2), activin A receptor type II-like 1 (ACVRL1) and transforming growth factor, beta receptor 1 (TGFBR1) kinase from pre- and post-treatment tissue samples in order to determine whether CD105 and stem cell activation occurs after exposure to anti-vascular endothelial growth factor (VEGF) therapy as predicted by laboratory models, and whether exposure to anti-endoglin monoclonal antibody TRC105 affects these changes.
II. To compare the soluble CD105 levels at baseline and after treatment between the group receiving bevacizumab alone and the group receiving bevacizumab in combination with anti-endoglin monoclonal antibody TRC105.
III. To compare TGFBR2 levels at baseline and after treatment between the group receiving bevacizumab alone and the group receiving bevacizumab in combination with anti-endoglin monoclonal antibody TRC105.
IV. To evaluate whether circulating tumor cells (CTCs) can be detected in this patient population using parylene membrane filter technology, and whether changes in CTC counts and CD105 expression on CTCs during therapy correspond to imagi
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome:
- PFS [ Time Frame: The duration of time from start of treatment to time of progression or death, assessed at 24 weeks ]The corresponding hypothesized PFS at 24 weeks would be 37% on the single-agent arm and 60% on the combination arm.
- Progression-free survival (PFS) [ Time Frame: The duration of time from start of treatment to time of progression or death, assessed at 12 weeks ]Planning is based on the supposition of 12-week PFS of 61% on the control arm and 78% on the combination arm.
Original Primary Outcome:
- Progression-free survival (PFS) [ Time Frame: The duration of time from start of treatment to time of progression or death, assessed at 12 weeks ]Planning is based on the supposition of 12-week PFS of 61% on the control arm and 78% on the combination arm.
- Progression-free survival (PFS) [ Time Frame: The duration of time from start of treatment to time of progression or death, assessed at 24 weeks ]The corresponding hypothesized PFS at 24 weeks would be 37% on the single-agent arm and 60% on the combination arm.
Current Secondary Outcome:
- Incidence of adverse events (AE) and toxicity of study treatment [ Time Frame: Up to 30 days post-treatment ]The descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be utilized for AE reporting.
- Response rate assessed by RECIST [ Time Frame: Up to 4 weeks ]
Original Secondary Outcome: Response rate assessed by RECIST [ Time Frame: Up to 4 weeks ]
Information By: National Cancer Institute (NCI)
Dates:
Date Received: November 12, 2012
Date Started: November 2012
Date Completion:
Last Updated: May 18, 2017
Last Verified: May 2017
