Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT01684397|
Recruitment Status : Recruiting
First Posted : September 13, 2012
Last Update Posted : March 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma Stage IV Renal Cell Cancer||Biological: Bevacizumab Other: Laboratory Biomarker Analysis Drug: Pazopanib Hydrochloride Other: Pharmacological Study||Phase 1 Phase 2|
- I. To determine the safe phase II dose of this novel regimen. (Phase I)
- II. To determine the median progression free survival (PFS) from this novel regimen. (Phase II)
I. To evaluate the safety and toxicity of the proposed regimen. (Phase I) II. To evaluate the response rate. (Phase I) III. To evaluate the pharmacokinetics of pazopanib (pazopanib hydrochloride). (Phase I) IV. To evaluate the vascular endothelial growth factor (VEGF) levels and myeloid derived suppressor cell (MDSC) levels at various time points and correlate with response. (Phase I) V. To evaluate the safety and toxicity of this new regimen. (Phase II) VI. To evaluate the VEGF levels, interleukin (IL)-8 levels and MDSC levels at various time points and correlate with outcome. (Phase II) VII. To evaluate the PFS rate at 12 months. (Phase II) VIII. To evaluate overall survival. (Phase II)
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive pazopanib hydrochloride orally (PO) on days 1-28, and bevacizumab intravenously (IV) over 30-90 minutes on days 36 and 50. Courses repeat every 70 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and Phase II patients are followed up by telephone every 12 months
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of Pazopanib Alternating With Bevacizumab in Treatment-Naive Metastatic Clear Cell Renal Cell Carcinoma Patients|
|Actual Study Start Date :||October 5, 2012|
|Estimated Primary Completion Date :||June 13, 2020|
|Estimated Study Completion Date :||July 13, 2021|
Experimental: Treatment (pazopanib hydrochloride and bevacizumab)
Patients receive pazopanib hydrochloride PO on days 1-28 and bevacizumab IV over 30-90 minutes on days 36 and 50. Courses repeat every 70 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Drug: Pazopanib Hydrochloride
Other: Pharmacological Study
- Median PFS (Phase II) [ Time Frame: Up to 30 days post-treatment ]Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.
- Optimal phase II dose, defined as the largest dose level at which less than 2 out of the 6 patients experienced dose-limiting toxicity, graded according to Common Terminology Criteria for Adverse Events version 4.0 (Phase I) [ Time Frame: Up to 140 days ]The frequency of toxicities will be tabulated for the dose estimated to be the maximum-tolerated dose.
- Incidence of grade 3 or higher toxicities, graded according to CTCAE version 4.0 [ Time Frame: Up to 30 days post-treatment ]Categorical variables will be summarized in contingency tables, with associations of interest assessed using Fisher's exact test. The frequency of toxicities will be tabulated by grade across all dose levels and courses.
- Overall survival (Phase II) [ Time Frame: From the date of study enrollment to the date of death from any cause, assessed up to 30 days post-treatment ]Will be obtained using Kaplan-Meier and Proportional Hazards methods.
- PFS rate at 12 months (Phase II) [ Time Frame: At 12 months ]Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.
- Response rate according to RECIST 1.1 (Phase I) [ Time Frame: Up to 30 days post-treatment ]
- IL-8 levels [ Time Frame: Up to 30 days post-treatment ]Distributions of continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.
- MDSC levels [ Time Frame: Up to 30 days post-treatment ]
- Pazopanib exposure as measured by pharmacokinetics parameters [ Time Frame: Course 1 on day 1 at pre-dose, 2 hours, and 4 hours post-dose; day 15 at pre-dose and 2 hours post-dose; and day 29 ]
- VEGF levels [ Time Frame: Up to 30 days post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684397
|United States, Kansas|
|The University of Kansas Cancer Center||Recruiting|
|Westwood, Kansas, United States, 66205|
|Contact: Jane Ledesma 913-588-0545 firstname.lastname@example.org|
|Principal Investigator: Rahul Parikh, MD|
|United States, Michigan|
|Karamanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 482018|
|Contact: Ulka Vaishampayan, MD 313-576-8715 email@example.com|
|Principal Investigator: Ulka Vaishamu, MD|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roswell Park 877-275-7724 ASKRPCI@roswellpark.org|
|Principal Investigator: Saby George|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute (UPCI)||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Rahul A. Parikh 412-692-4724 firstname.lastname@example.org|
|Principal Investigator: Rahul A. Parikh|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Deepak Kilari, MD 414-805-3666|
|Principal Investigator:||Saby George||Roswell Park Cancer Institute|