Brief Title
S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
Official Title
A Phase II Trial of Novel Oral Anti-Angiogenic Agent AZD2171 (NSC-732208) in Malignant Pleural Mesothelioma
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall Response Rate
Secondary Outcome
Overall Survival
Condition
Advanced Malignant Mesothelioma
Intervention
cediranib maleate
Study Arms / Comparison Groups
Treatment (cediranib maleate)
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
54
Start Date
November 2005
Completion Date
December 2011
Primary Completion Date
April 2010
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Linda Garland, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00243074
Organization ID
NCI-2012-02902
Secondary IDs
S0509
Responsible Party
Sponsor
Study Sponsor
National Cancer Institute (NCI)
Study Sponsor
Linda Garland, Principal Investigator, Southwest Oncology Group
Verification Date
February 2014