Pazopanib Hydrochloride in Treating Patients With Stage IV Kidney Cancer

Phase 2

Completed

Conditions: Stage IV Renal Cell Cancer
Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer

Interventions: Drug: pazopanib hydrochloride
Other: laboratory biomarker analysis
Other: immunologic technique

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm I	pazopanib hydrochloride	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.
Arm I	laboratory biomarker analysis	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.
Arm I	immunologic technique	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.

Primary Outcome Measures

Name	Time	Method
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by RECIST 1.1 Criteria	1 year post treatment	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	1 year post treatment	One-year Kaplan-Meier estimate of survival, given in percent, with a 95% Confidence Interval based on the Greenwood variance, with log-log transform.
Progression-free Survival	1 year post treatment	Kaplan-meier estimate of Progression-free survival, one-year post enrollment in the study. 95% Confidence Intervals are constructed using the Greenwood estimate of variance and log-log transformation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or an unequivocal measured increase in a non-target lesion, or the appearance of new lesions