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

NCT ID: NCT00243074

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2011-12-31

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.

Conditions

Advanced Malignant Mesothelioma; Epithelial Mesothelioma; Recurrent Malignant Mesothelioma; Sarcomatous Mesothelioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (cediranib maleate)

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

cediranib maleate

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

cediranib maleate

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

AZD2171; Recentin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Garland

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

Southwest Oncology Group

San Antonio, Texas, United States

Countries

United States

Other Identifiers

S0509

Identifier Type: -

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000446178

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02902

Identifier Type: -

Identifier Source: org_study_id