NCT00471536 · REGISTRY CONDITION SEARCH

Pazopanib in Treating Patients With Metastatic Urothelial Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2014-05-30

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 the enzymes needed for cell growth and by blocking blood flow to the tumor.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Best Tumor Response (Complete [CR] or Partial Response [PR] by Response Evaluation Criteria in Solid Tumors [RECIST])

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outcome · POSTED

Adverse Events Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

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outcome · POSTED

Confirmed Tumor Response (CR and PR)

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outcome · POSTED

Duration of Response

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outcome · POSTED

Time to Disease Progression

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outcome · POSTED

Survival Time

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: pazopanib hydrochloride
label
Treatment (enzyme inhibitor therapy)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (enzyme inhibitor therapy)
description
800 mg Given orally
name
pazopanib hydrochloride
other Names
GW786034B
Votrient
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 19
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
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.

secondary Outcomes

description
The maximum grade for each adverse event considered to be at least possibly related to treatment will be recorded. Frequency tables will be constructed.
measure
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)
description
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.
measure
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
description
The distribution of response durations will be estimated using the Kaplan-Meier method.
measure
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
description
The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.
measure
Time to Disease Progression
time Frame
Every 3 months from registration until progressive disease (PD), assessed up to 2 years after registration
description
The distribution of survival times will be estimated using the Kaplan-Meier method.
measure
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

Full study description

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 the enzymes needed for cell growth and by blocking blood flow to the tumor.
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 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.

Source references

Source notices and limitations

Discovery and provenance

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exact text
NCT00471536
start
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offset unit
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query cond
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query disease state id
ds-urethral-cancer
source file
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source url
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Preserved source evidence · Not medical advice