NCT00934440

A Study to Evaluate the Effectiveness of 5-Azacitidine and Bevacizumab in Advanced Renal Cell Carcinoma

A Phase I/II Study Evaluating The Efficacy OF 5-Azacitidine And Bevacizumab In Advanced Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	* 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).
DRUG	Azacitidine	* 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

Timeline

• Start date: 2009-06-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2009-07-08
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

2 sites across 1 country: United States