Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Azacitidine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Enzyme Inhibitors

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.

* 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

Peter J Van Veldhuizen, MD

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.

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

Toxicities determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

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.

Celgene

University of Kansas Medical Center

All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.

Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Peter Van Velduizen

AEs at dose level 1

AEs at dose level 2

AEs at dose level 3

5-Azacitidine Maximum Tolerated Dose (MTD)

Toxicities by Dose Level

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.

Bevacizumab:

* First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1
* Second treatment: 10 MG/KG IV on Day 1
* Third and subsequent treatments: 10 MG/KG IV on Day 1

Dose Escalation: 5-azacitidine

Time to Progression

Overall Study

Spots Global Cancer Trial Database for A Study to Evaluate the Effectiveness of 5-Azacitidine and Bevacizumab in Advanced Renal Cell Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial