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Advanced Malignant MesotheliomaPhase 2NCT00243074

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

A Phase 2 study testing cediranib maleate and laboratory biomarker analysis in people with Advanced Malignant Mesothelioma and Epithelial Mesothelioma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cediranib maleate and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
Nov 2005to Dec 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 41Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Southwest Oncology Group

    San Antonio, Texas, 78245

Other trials in United States

About this study

Official title: A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the objective confirmed, complete, and partial response rates in patients with unresectable malignant pleural mesothelioma treated with AZD2171.

SECONDARY OBJECTIVES:

  1. 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.

  1. 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.

Being tested
cediranib maleate, laboratory biomarker analysis
Medical subject headings
Mesothelioma, Malignant, Solitary Fibrous Tumor, Pleural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cediranib maleateDrug

    Also called AZD2171, Recentin

    Given orally

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00243074
Study groupRoleWhat they receive
Treatment (cediranib maleate)ExperimentalPatients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: cediranib maleate; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    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.".

    Measured: 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 (6)

  1. Overall Survival

    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.

    Measured: Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.

  2. Progression-free Survival

    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

    Measured: Every 8 weeks until disease progression or death, up to 5 years.

  3. Disease Control Rate

    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.

    Measured: Every 8 weeks until disease progression progression, up to 5 years.

  4. Objective Response Rate Per Modified RECIST for Pleural Tumors

    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.

    Measured: Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.

  5. Adverse Event Rates

    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.

    Measured: Daily during protocol treatment

  6. Adverse Events

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Patients were assessed for adverse events every day for as long as they remained on protocol treatment, up to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionApr 2010
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00243074
Sponsor's protocol ID
NCI-2012-02902
Other IDs
S0509, U10CA032102, CDR0000446178
Status last verified
Feb 2014
First submitted
20 Oct 2005
Last updated
23 Jan 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cediranib maleate and laboratory biomarker analysis in people with Advanced Malignant Mesothelioma and Epithelial Mesothelioma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00243074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

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