NCT00243074 · REGISTRY CONDITION SEARCH

S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery

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: 2018-01-23

This phase II trial is study how well AZD2171 works in treating patients with malignant pleural mesothelioma that cannot be removed by surgery. AZD2171 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

Overall Response Rate

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Disease Control Rate

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outcome · POSTED

Objective Response Rate Per Modified RECIST for Pleural Tumors

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outcome · POSTED

Adverse Event Rates

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outcome · POSTED

Adverse Events

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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 confirmed epithelial, sarcomatous, or biphasic malignant pleural mesothelioma * Unresectable disease * Residual disease after prior cytoreductive surgery allowed * Measurable disease by CT scan or MRI * Prior treatment with platinum-based chemotherapy required * No known CNS metastasis * Performance status * Zubrod 0-2 * WBC \>= 3,000/mm\^3 * Absolute neutrophil count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * AST or ALT =\< 1.5 times upper limit of normal (ULN) * Bilirubin normal * Creatinine =\< 1.5 times ULN OR * Creatinine clearance \>= 50 mL/min * Proteinuria =\< 1+ by 2 consecutive dipstick tests taken \>= 1 week apart * No history of familial long QT syndrome * Mean QTc =\< 470 msec * Systolic BP =\< 150 mm Hg AND diastolic BP =\< 100 mm Hg * Must have New York Heart Association class I or II disease * Class II must be controlled with treatment * Able to swallow and/or receive enteral medications via gastrostomy feeding tube * Not requiring IV alimentation * No active peptic ulcer * No intractable nausea or vomiting * Not pregnant or nursing * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in remission * No history of hypersensitivity reaction to compounds of similar chemical or biological composition to the study drug * Prior monoclonal antibody therapy targeting vascular endothelial growth factor (VEGF), VEGF receptor 1(VEGFR1) or VEGF receptor 2 (VEGFR2) allowed * No other prior immunotherapy or biologic therapy * No prior thymidine kinase inhibitor against VEGFR1 or VEGFR2 * No concurrent drugs or biologics with proarrhythmic potential * No more than 1 prior chemotherapy regimen * At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and recovered * At least 21 days since prior radiotherapy and recovered * At least 28 days since prior major surgery (e.g., thoracotomy or laparotomy) and recovered * No prior surgery that would affect absorption * Stable antihypertensive therapy allowed provided blood pressure (BP) parameters are met * Concurrent enrollment on SWOG-S9925 allowed * No concurrent combination antiretroviral therapy for HIV-positive patients
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
intervention Names
Drug: cediranib maleate
Other: laboratory biomarker analysis
label
Treatment (cediranib maleate)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (cediranib maleate)
description
Given orally
name
cediranib maleate
other Names
AZD2171
Recentin
type
DRUG
arm Group Labels
Treatment (cediranib maleate)
description
Correlative studies
name
laboratory biomarker analysis
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 54
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
measure
Overall Response Rate
time Frame
Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.

secondary Outcomes

description
From the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
measure
Overall Survival
time Frame
Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.
description
From the date of enrollment until the date of disease progression (as determined by standard RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
measure
Progression-free Survival
time Frame
Every 8 weeks until disease progression or death, up to 5 years.
description
The percentage of patients with a best of response of stable disease or better per standard RECIST. That is, patients whose best response was not increasing disease or death.
measure
Disease Control Rate
time Frame
Every 8 weeks until disease progression progression, up to 5 years.
description
The sum of 6 pleural thickness measurements is added to sum of the longest diameters of all non-pleural measurable lesions. The resulting values are evaluated using RECIST.
measure
Objective Response Rate Per Modified RECIST for Pleural Tumors
time Frame
Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.
description
Adverse events per the NCI Common Toxicity Criteria version 3.0 that were possibly, probably or definitely related to protocol treatment. See adverse event tables for specific details.
measure
Adverse Event Rates
time Frame
Daily during protocol treatment
description
Only adverse events that are possibly, probably or definitely related to study drug are reported.
measure
Adverse Events
time Frame
Patients were assessed for adverse events every day for as long as they remained on protocol treatment, up to 5 years.

Full study description

brief Summary: This phase II trial is study how well AZD2171 works in treating patients with malignant pleural mesothelioma that cannot be removed by surgery. AZD2171 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. Determine the objective confirmed, complete, and partial response rates in patients with unresectable malignant pleural mesothelioma treated with AZD2171. SECONDARY OBJECTIVES: I. Determine the clinical benefit, in terms of objective response and stable disease rates, in patients treated with this drug. II. Determine the 1-year median overall survival and progression-free survival in patients treated with this drug. III. Determine the frequency and severity of toxic effects in patients treated with this drug. IV. Correlate, preliminarily, pre- and post-treatment plasma vascular endothelial growth factor and soluble vascular cell adhesion molecule with clinical outcomes in patients treated with this drug. V. Correlate, preliminarily, circulating endothelial cells with clinical outcomes in patients treated with this drug. VI. Correlate variants of genes in the pathway targeted by this drug and variants of genes involved in the development of hypertension with the antiangiogenic property of this drug in these patients. OUTLINE: Patients receive oral AZD2171 once daily 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 periodically for up to 5 years from study entry.

Source references

Source notices and limitations

Discovery and provenance

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exact text
NCT00243074
start
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query cond
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query disease state id
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source file
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source url
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Preserved source evidence · Not medical advice