Sorafenib Tosylate and Stereotactic Radiosurgery in Treating Patients With Brain Metastases
RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Stereotactic radiosurgery (SRS) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving sorafenib tosylate together with SRS may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and the best dose of sorafenib tosylate when given together with SRS in treating patients with brain metastases
Tumors Metastatic to Brain
Drug: sorafenib tosylate
Radiation: stereotactic radiosurgery
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Sorafenib and Stereotactic Radiosurgery for Patients With 1-4 Brain Metastases|
- The maximum tolerated dose (MTD) of combining sorafenib with SRS [ Time Frame: At 1 month ] [ Designated as safety issue: Yes ]
- Intra-cranial progression-free survival (PFS) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
- Overall survival(OS) in study patient population [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||September 2018|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
See Detailed Description
Drug: sorafenib tosylate
Other Names:Radiation: stereotactic radiosurgery
Undergo stereotactic radiosurgeryOther: laboratory biomarker analysis
I. To determine the safety, tolerability and maximum tolerated dose (MTD) of sorafenib, when administered in combination with SRS to patients with 1-4 metastatic brain tumors.
I. To assess the six-month intra-cranial progression-free survival (PFS) of sorafenib when administered in combination with SRS to patients with 1-4 metastatic brain tumors. PFS is defined as the time to intra-cranial tumor progression or death.
II. To assess the six-month overall survival (OS) of sorafenib when administered in combination with SRS to patients with 1-4 metastatic brain tumors.
III. To compare results to patients who are treated with SRS alone (concurrent controls).
OUTLINE: This is a dose-escalation study of sorafenib tosylate.
Patients receive oral (PO) sorafenib tosylate once daily and undergo SRS 5-7 days later. Treatment with sorafenib continues for 2 weeks after SRS in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 8, 26, and 52 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276210
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Anuradha Chakravarthy||Vanderbilt-Ingram Cancer Center|