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

Phase 1

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: Bevacizumab; Drug: Azacitidine

• Registration Number: NCT00934440
• Lead Sponsor: University of Kansas Medical Center

Brief 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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2017-01-12
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-09
• Last Update Submitted: 2017-05-09
• Results First Posted: 2017-06-14
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation: 5-azacitidine	Azacitidine	A traditional 3+3 dose escalation trial was implemented. Successive cohorts of patients (3 participants/cohort) received bevacizumab at the standard dose of 10mg/kg in combination with escalating doses of 5-azacitidine. If no dose limiting toxicity (DLT) is seen, subsequent patients will be treated at the next dose level. If one DLT is seen, an additional three patients will be accrued at that dose level. If two or more DLTs are seen at one dose level, then the previous dose level will be chosen for phase IIA. If two DLT's are seen at dose level 1, the trial will end. The standard 5-azacitidine dose is 75mg/m2/day for 7 days. If no DLT is seen at dose level 3, then we will proceed with the phase IIA portion of the study.
Dose Escalation: 5-azacitidine	Bevacizumab	A traditional 3+3 dose escalation trial was implemented. Successive cohorts of patients (3 participants/cohort) received bevacizumab at the standard dose of 10mg/kg in combination with escalating doses of 5-azacitidine. If no dose limiting toxicity (DLT) is seen, subsequent patients will be treated at the next dose level. If one DLT is seen, an additional three patients will be accrued at that dose level. If two or more DLTs are seen at one dose level, then the previous dose level will be chosen for phase IIA. If two DLT's are seen at dose level 1, the trial will end. The standard 5-azacitidine dose is 75mg/m2/day for 7 days. If no DLT is seen at dose level 3, then we will proceed with the phase IIA portion of the study.

Primary Outcome Measures

Name	Time	Method
Toxicities by Dose Level	3 to 6 months	Toxicities determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

Secondary Outcome Measures

Name	Time	Method
Time to Progression	2 years	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.

Trial Locations

Locations (2)

Stormont-Vail Cotton O'Neil Cancer Center; 🇺🇸 Topeka, Kansas, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States