Clinical Trial: Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Efficacy Trial of Pazopanib in Non-clear Cell Metastatic Renal Cell Cancer (mRCC) PINCR

Brief Summary: This phase II trial studies how well pazopanib hydrochloride works in treating patients with kidney cancer that has spread to other places in the body (metastatic). 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.

Detailed Summary:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.


Sponsor: Mayo Clinic

Current Primary Outcome: Overall survival rate [ Time Frame: 12 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse event rate, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ]
    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.
  • Progression-free survival [ Time Frame: From registration to the earliest date documentation of disease progression or death, assessed up to 2 years ]
    Kaplan-Meier curve will be used to estimate progression-free survival time.
  • Retreatment of patients who have relapsed [ Time Frame: Up to 2 years ]
    Statistical analysis of the observational phase data for these patients will be of a descriptive nature.
  • Tumor response rate, according to the Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 2 years ]
    A tumor response is defined to be a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 8 weeks apart.


Original Secondary Outcome:

  • Tumor response rate, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 2 years ]
    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 ]
    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 ]
    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.


Information By: Mayo Clinic

Dates:
Date Received: January 10, 2013
Date Started: May 2013
Date Completion: May 2018
Last Updated: March 6, 2017
Last Verified: November 2016