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

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

Thank you

Trial Information

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



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


- Determine the clinical benefit, in terms of objective response and stable disease
rates, in patients treated with this drug.

- Determine the 1-year median overall survival and progression-free survival in patients
treated with this drug.

- Determine the frequency and severity of toxic effects in patients treated with this

- 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.

- Correlate, preliminarily, circulating endothelial cells with clinical outcomes in
patients treated with this drug.

- 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: This is a multicenter study.

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.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed epithelial, sarcomatous, or biphasic malignant pleural

- 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

Life expectancy

- Not specified


- 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


Biologic therapy

- 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 proarrythmic potential


- See Disease Characteristics

- No more than 1 prior chemotherapy regimen

- At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and


- At least 21 days since prior radiotherapy and recovered


- See Disease Characteristics

- At least 28 days since prior major surgery (e.g., thoracotomy or laparotomy) and

- No prior surgery that would affect absorption


- Stable antihypertensive therapy allowed provided blood pressure (BP) parameters are

- Concurrent enrollment on SWOG-S9925 allowed

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (complete response and partial response)

Outcome Time Frame:

3 years or until death

Safety Issue:


Principal Investigator

Linda Garland, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona


United States: Federal Government

Study ID:




Start Date:

November 2005

Completion Date:

April 2010

Related Keywords:

  • Malignant Mesothelioma
  • epithelial mesothelioma
  • sarcomatous mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • Mesothelioma



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