Pazopanib in Treating Patients With Metastatic Non-Clear Cell Kidney Cancer
This phase II trial studies how well pazopanib hydrochloride works in treating patients with metastatic kidney cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of kidney cancer by blocking blood flow to the tumor
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Type 1 Papillary Renal Cell Carcinoma
Type 2 Papillary Renal Cell Carcinoma
Drug: pazopanib hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Efficacy Trial of Pazopanib in Non-Clear Cell Metastatic Renal Cell Cancer (mRCC) PINCR|
- Overall survival rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]A "12-month overall survivor" will be considered synonymous with "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated.
- Tumor response rate, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]A tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart.
- Progression-free survival [ Time Frame: From registration to the earliest date documentation of disease progression or death, assessed up to 2 years ] [ Designated as safety issue: No ]Kaplan-Meier curve will be used to estimate progression-free survival time.
- Adverse event rate, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.
|Study Start Date:||May 2013|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
I. To determine the efficacy of pazopanib (pazopanib hydrochloride) in non clear cell metastatic renal cell cancer patients as assessed by the overall survival rate at 12 months.
I. To determine the rates of best tumor response at the end of the first two treatment cycles of pazopanib in non clear cell metastatic renal cell cancer patients.
II. To determine the benefit of pazopanib in increasing progression free survival time.
III. To describe toxicity profile of pazopanib in non clear cell metastatic renal cell cancer patients.
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) 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 for 2 years.
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Mayo Clinic Clinical Trials Referral Office 507-538-7623|
|Principal Investigator: Brian A. Costello, M.D.|
|Study Chair:||Brian A. Costello, M.D.||Mayo Clinic|