Carfilzomib in Refractory Renal Cell Carcinoma (RCC)
The goal of this clinical research study is learn if carfilzomib can help control kidney cancer. The safety of this drug will also be studied.
Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Carfilzomib in Patients With Refractory Renal Cell Carcinoma|
- Progression Free Survival (PFS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Progression free survival defined as time from enrollment to progression or death, whichever comes first. Progression defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Any patients who are alive and free of disease at time of analysis censored at date of most recent tumor assessment. Response defined as complete response or partial response by RECIST. Overall survival defined as time from enrollment to death, regardless of cause. Patients who are alive at time of analysis censored on date they were last in contact with study personnel.
- Safety of Carfilzomib Treatment in Patients with Metastatic Renal Cell Carcinoma (RCC) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Adverse events recorded by Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 with information regarding relationship to the study drug. Whether or not a patient had to be discontinued from therapy due to predefined severe toxicity also recorded.
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||October 2019 (Final data collection date for primary outcome measure)|
Patients receive Carfilzomib at dose of 20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01775930
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eric Jonasch, MD||UT MD Anderson Cancer Center|