Pazopanib in Treating Patients With Metastatic Urothelial Cancer
Distal Urethral Cancer
Proximal Urethral Cancer
Recurrent Bladder Cancer
Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
Recurrent Urethral Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Urethral Cancer Associated With Invasive Bladder Cancer
Drug: pazopanib hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Safety and Efficacy Study With the VEGF Receptor Tyrosine Kinase Inhibitor GW786034 in Patients With Metastatic Urothelial Cancer|
- Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST]) [ Time Frame: Participants will be evaluated every 8 weeks during treatment and up to 1 year after completion of treatment. ] [ Designated as safety issue: No ]
Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. Per RECIST v1.0 criteria:
A Complete Response (CR) requires the disappearance of all target lesions.
A Partial Response (PR) requires >=30% decrease in the sum of the longest diameter of target lesions from baseline measurement.
All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.
- Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: Every 4 weeks during treatment (maximum duration was 44 weeks) ] [ Designated as safety issue: Yes ]The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.
- Confirmed Tumor Response (CR and PR) [ Time Frame: Documented on 2 consecutive evaluations 8 weeks apart from the start of the treatment until disease progression/recurrence, assessed up to 1 year ] [ Designated as safety issue: No ]Tumor response is defined as the total number of eligible patients whose disease has a complete or partial response to GW786034 according to the RECIST criteria. A confirmed response is defined as a CR or PR and is documented on 2 consecutive evaluations.
- Duration of Response [ Time Frame: From the time an objective response is first noted to be either a CR or PR to the date progression is documented, assessed up to 1 year ] [ Designated as safety issue: No ]The distribution of response durations will be estimated using the Kaplan-Meier method.
- Time to Disease Progression [ Time Frame: Every 3 months from registration until progressive disease (PD), assessed up to 2 years after registration ] [ Designated as safety issue: No ]The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.
- Survival Time [ Time Frame: Time from registration until death due to any cause, assessed every 6 months after PD for up to 2 years after registration ] [ Designated as safety issue: No ]The distribution of survival times will be estimated using the Kaplan-Meier method.
|Study Start Date:||August 2008|
|Study Completion Date:||December 2013|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: pazopanib hydrochloride
800 mg Given orally
I. Assess the anti tumor activity and toxicity profile of pazopanib hydrochloride in patients with metastatic urothelial cancer.
I. Evaluate the pharmacokinetics of pazopanib hydrochloride in these patients. II. Evaluate pre- and post-treatment changes in circulating endothelial cells, monocytes and platelets, and angiogenesis-related factors in these patients.
OUTLINE: This is a multicenter study. Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically for correlative studies and pharmacological studies. Samples are analyzed for vascular endothelial growth factor (VEGF) and soluble VEGF receptor II concentration via ELISA. Circulating endothelial cells are also measured.
After completion of study treatment, patients are followed for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471536
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287-8936|
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48202|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Cox Medical Center|
|Springfield, Missouri, United States, 65807|
|China, Hong Kong|
|Chinese University of Hong Kong-Prince of Wales Hospital|
|Shatin, Hong Kong, China, OX1 3UJ|
|Korea, Republic of|
|Gangnam Severance Hospital|
|Seoul, Korea, Republic of, 120-752|
|Principal Investigator:||Ulka Vaishampayan||Mayo Clinic|