Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer
Carcinoma of the Collecting Ducts of Bellini
Chromophobe Renal Cell Carcinoma
Kidney Medullary Carcinoma
Papillary Renal Cell Carcinoma
Recurrent Renal Cell Carcinoma
Sarcomatoid Renal Cell Carcinoma
Stage IV Renal Cell Cancer
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.
- 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 ] [ 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.
- 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.
- Retreatment of patients who have relapsed [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767636
|United States, Arizona|
|Mayo Clinic in Arizona||Recruiting|
|Scottsdale, Arizona, United States, 85259|
|Contact: Thai H. Ho 480-301-8000|
|Principal Investigator: Thai H. Ho|
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224-9980|
|Contact: Winston W. Tan 904-953-2000 email@example.com|
|Principal Investigator: Winston W. Tan|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015|
|Principal Investigator: Brian A. Costello|
|Principal Investigator:||Brian Costello||Mayo Clinic|