To identify the maximum tolerable dose and assess qualitative/quantitative toxicities in patients with advanced renal cell cancer treated with combination of 5-azacitidine and bevacizumab.
In this study, the investigator will assess progression-free and overall survival of patients with advanced renal cell carcinoma treated with 5-azacitidine in combination with bevacizumab. Patients will continue on treatment until either disease progression or development of other criteria for withdrawal.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
11
* First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1every two weeks over 90 minutes. * Second treatment: 10 MG/KG IV on Day 1 every two weeks over 60 minutes. * Third and subsequent treatments: 10 MG/KG IV on Day 1 every two weeks over 30 minutes (minimum of two cycles).
* Dose level 1: 35 mg/m2/day for 7 days. * Dose level 2: 55 mg/m2/day for 7 days. * Dose level 3: 75 mg/m2/day for 7 days. * mg/m2/day = dose based on height and weight
University of Kansas Medical Center
Kansas City, Kansas, United States
Stormont-Vail Cotton O'Neil Cancer Center
Topeka, Kansas, United States
Toxicities by Dose Level
Toxicities determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time frame: 3 to 6 months
Time to Progression
The time to progression was measured using time from the first day of treatment to the first day of an evaluation of progressive disease or the date of death for any cause.
Time frame: 2 years
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