Pazopanib Hydrochloride in Treating Patients With Stage IV Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT01157091|
Recruitment Status : Active, not recruiting
First Posted : July 5, 2010
Last Update Posted : May 17, 2018
RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating patients with stage IV kidney cancer.
|Condition or disease||Intervention/treatment||Phase|
|Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer||Drug: pazopanib hydrochloride Other: laboratory biomarker analysis Other: immunologic technique||Phase 2|
I. To determine the response rate (RR) associated with pazopanib (pazopanib hydrochloride) as 3rd-line therapy in metastatic renal cell carcinoma (mRCC) patients who have failed therapy with a distinct vascular endothelial growth factor (VEGF)-tyrosine kinase inhibitor (TKI).
I. To determine if baseline hepatocyte growth factor (HGF), endothelial selectin (E-selectin) and interleukin-6 (IL-6) are associated with progression-free survival (PFS).
II. To determine if pre-metastatic niche density in regional lymph nodes (LNs) is associated with PFS.
III. To determine an association between E-selectin, IL-6 and pre-metastatic niche density.
IV. To evaluate the prognostic effect of pre-metastatic niches as an independent factor in time to first relapse.
V. To determine if phosphorylated signal transducer and activator of transcription 3 (pSTAT3) in tumor tissue is associated with PFS.
VI. To describe the toxicity associated with pazopanib in this patient population.
VII. To evaluate PFS and overall survival (OS). VIII. To compare, within patient, time to tumor progression of 2nd-line therapy with time to tumor progression on pazopanib as 3rd-line therapy.
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Pazopanib in VEGF-TKI Refractory Metastatic Renal Cell Carcinoma (MRCC)|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: Arm I
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
Other: laboratory biomarker analysis
Other: immunologic technique
- Confirmed response rate (complete response and partial response) as assessed by RECIST 1.1 criteria [ Time Frame: 1 year post treatment ]
- Toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 1 year post treatment ]
- Progression-free survival [ Time Frame: 1 year post treatment ]
- Overall survival [ Time Frame: 1 year post treatment ]
- Association of baseline E-selectin with progression-free survival [ Time Frame: At baseline ]
- Association of baseline IL-6 with progression-free survival [ Time Frame: At baseline ]
- Pre-metastatic niche density [ Time Frame: At baseline ]
- Association of pSTAT3 in tumor tissue with progression-free survival [ Time Frame: At baseline ]
- Association of baseline HGF with progression-free survival [ Time Frame: At baseline ]
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): NCT01157091
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|South Pasadena Cancer Center|
|Pasadena, California, United States, 91030|
|Principal Investigator:||Sumanta Pal||City of Hope Medical Center|