Sunitinib Malate and Bevacizumab in Treating Patients With Kidney Cancer or Advanced Solid Malignancies
|ClinicalTrials.gov Identifier: NCT01243359|
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : April 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage I Renal Cell Cancer Stage II Renal Cell Cancer Stage III Renal Cell Cancer Stage IV Renal Cell Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: sunitinib malate Biological: bevacizumab Other: pharmacological study Other: laboratory biomarker analysis Other: fluorine F 18 fluorothymidine Procedure: positron emission tomography Procedure: computed tomography||Phase 1|
I. To evaluate the safety and tolerability of sequential sunitinib (sunitinib malate) with bevacizumab in patients with clear cell kidney cancer.
II. To assess the objective response rate of sequential sunitinib with bevacizumab in patients with clear cell kidney cancer.
I. To determine the pharmacodynamic change in standardized uptake values (SUV) peak and tumor perfusion using fluorine F 18 fluorothymidine positron emission tomography (FLT-PET)/computed tomography (CT) scans at baseline, during sunitinib exposure, and during bevacizumab exposure (during sunitinib withdrawal period) in patients with renal cell and other solid malignancies.
II. To characterize changes in the ratio of free: bound plasma vascular endothelial growth factor (VEGF) in patients treated with sequential sunitinib with bevacizumab.
OUTLINE: This is a dose-escalation study of sunitinib malate.
Patients receive sunitinib malate orally (PO) on days 1-28 and bevacizumab intravenously (IV) over 30-90 minutes on day 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Pharmacodynamic Trial of Sequential Sunitinib With Bevacizumab in Patients With Renal Cell Carcinoma and Other Advanced Solid Malignancies|
|Study Start Date :||October 2010|
|Primary Completion Date :||February 2014|
Experimental: Treatment (sunitinib malate, bevacizumab)
Patients receive sunitinib malate PO on days 1-28 and bevacizumab IV over 30-90 minutes on day 29. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
Other Names:Biological: bevacizumab
Other Names:Other: pharmacological study
Other Name: pharmacological studiesOther: laboratory biomarker analysis
Correlative studiesOther: fluorine F 18 fluorothymidine
Undergo FLT PET/CT
Other Names:Procedure: positron emission tomography
Undergo FLT PET/CT
Other Names:Procedure: computed tomography
Undergo FLT PET/CT
Other Name: tomography, computed
- Proportion of patients with grade 3 or higher toxicities and recommended phase II dose of sunitinib in the presence of bevacizumab or sunitinib alone graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 6 weeks ]
- Objective response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 2 years ]Responses will be summarized using descriptive statistics and frequency tables. Two-sided 95% confidence intervals for the proportions of subjects with a confirmed anti-tumor response will be computed for the two treatment schedules of sunitinib malate
- Pharmacodynamic change in SUV peak and tumor perfusion using FLT PET/CT [ Time Frame: Baseline, at 4 weeks and 6 weeks of course 1 ]Summarized in terms of means, standard deviations and ranges. Percentage changes will be computed and formally compared using paired t-tests and/or the nonparametric Wilcoxon Signed Rank test, should the normality assumption be violated.
- Changes in the ration of free-bound plasma VEGF by Enzyme-linked immuno sorbent assay (ELISA) [ Time Frame: Baseline to 2 years ]Plasma VEGF will be summarized using descriptive statistics such as means, standard deviations and ranges. Changes from baseline will be evaluated using paired t-tests and/or nonparametric Wilcoxon Signed Rank tests, should the normality assumption be violated and should no normality-improving transformation be found
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243359
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Glenn Liu||University of Wisconsin, Madison|