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Status:

COMPLETED

Pazopanib in Treating Patients With Metastatic Urothelial Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Distal Urethral Cancer

Proximal Urethral Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This phase II trial is studying the side effects and how well pazopanib works in treating patients with metastatic urothelial cancer. Pazopanib may stop the growth of tumor cells by blocking some of t...

Detailed Description

PRIMARY OBJECTIVES: I. Assess the anti tumor activity and toxicity profile of pazopanib hydrochloride in patients with metastatic urothelial cancer. SECONDARY OBJECTIVES: I. Evaluate the pharmacoki...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically or cytologically confirmed transitional cell cancer of the urothelium or bladder
  • Metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
  • No known brain metastases
  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Platelet count ≥ 100,000/mm\^3
  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • PT/INR/PTT ≤ 1.2 times ULN
  • No proteinuria \> 1+ on two consecutive dipsticks measured ≥ 1 week apart
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents used in the study
  • No condition that impairs the ability to swallow and retain pazopanib hydrochloride tablets, including any of the following:
  • Gastrointestinal tract disease resulting in an inability to take oral medication
  • Requirement for IV alimentation
  • Prior surgical procedures affecting absorption
  • Active peptic ulcer disease
  • No uncontrolled illness that would limit compliance with study therapy including, but not limited to, any of the following:
  • Ongoing or active infection
  • Psychiatric illness or social situations
  • No QTc prolongation (defined as a QTc interval ≥ 480 msecs) or other significant ECG abnormalities (e.g., frequent ventricular ectopy, evidence of ongoing myocardial ischemia)
  • No other conditions, including any of the following:
  • Serious or non-healing wound, ulcer, or bone fracture
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
  • Cerebrovascular accident within the past 6 months
  • Myocardial infarction, cardiac arrhythmia, or admission for unstable angina within the past 12 weeks
  • Venous thrombosis within the past 12 weeks
  • New York Heart Association (NYHA) class III or IV heart failure
  • Asymptomatic NYHA class II heart failure on treatment allowed
  • No other active second malignancy other than non-melanoma skin cancer
  • Patients are not considered to have an active malignancy if they have completed anti-cancer therapy and are considered by their physician to be ≤ 30% risk of relapse
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • At least 4 weeks since prior radiotherapy
  • Prior palliative radiotherapy to metastatic lesions allowed provided there is ≥ 1 measurable and/or evaluable lesion(s) that has not been irradiated
  • At least 4 weeks since prior surgery
  • One prior chemotherapy regimen for metastatic urothelial or bladder cancer
  • More than 12 weeks since prior cardiac angioplasty or stenting
  • Prior adjuvant or neoadjuvant therapy allowed
  • No prior experimental treatment for metastatic disease
  • No other prior or concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent CYP2C9 substrates, including any of the following:
  • Anticoagulants (e.g., warfarin \[therapeutic doses only\])
  • Low molecular weight heparin and prophylactic low-dose warfarin (≤ 2 mg daily) allowed
  • Oral hypoglycemics (e.g., glipizide, glyburide, tolbutamide, glimepiride, or nateglinide)
  • Ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine, or methylergonovine)
  • Antipsychotics (e.g., pimozide or clozapine)
  • Erectile dysfunction agents (e.g., sildenafil, tadalafil, or vardenafil)
  • Antiarrhythmics (e.g., bepridil, flecainide, lidocaine, mexiletine, amiodarone, quinidine, or propafenone)
  • Immune modulators (e.g., cyclosporine, tacrolimus, or sirolimus)
  • Miscellaneous drugs (e.g., theophylline, quetiapine, risperidone, tacrine, or atomoxetine)
  • No other concurrent anticancer agents or therapies
  • No concurrent medications that are associated with a risk of QTc prolongation and/or Torsades de Pointes

Exclusion

    Key Trial Info

    Start Date :

    August 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2013

    Estimated Enrollment :

    19 Patients enrolled

    Trial Details

    Trial ID

    NCT00471536

    Start Date

    August 1 2008

    End Date

    December 1 2013

    Last Update

    May 30 2014

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Mayo Clinic in Florida

    Jacksonville, Florida, United States, 32224-9980

    2

    Johns Hopkins University

    Baltimore, Maryland, United States, 21287-8936

    3

    Wayne State University

    Detroit, Michigan, United States, 48202

    4

    Mayo Clinic

    Rochester, Minnesota, United States, 55905