NCT01157091

Pazopanib Hydrochloride in Treating Patients With Stage IV Kidney Cancer

A Phase II Study of Pazopanib in VEGF-TKI Refractory Metastatic Renal Cell Carcinoma (MRCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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). SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Clear Cell Renal Cell Carcinoma
• Recurrent Renal Cell Cancer
• Stage IV Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	pazopanib hydrochloride	Given orally
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	immunologic technique	Correlative studies

Timeline

• Start date: 2010-12-08
• Primary completion: 2013-10-17
• Completion: 2013-12-31
• First posted: 2010-07-05
• Last updated: 2022-06-08
• Results posted: 2022-04-05

Locations

2 sites across 1 country: United States