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Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma

Phase 2
18 Years
Open (Enrolling)
Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Localized Malignant Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma

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Trial Information

Phase II Study of AZD2171 (NSC#732208) in Patients With Malignant Mesothelioma


I. Determine the objective response rate in patients with malignant pleural, peritoneal, or
tunica vaginalis mesothelioma that is not amenable to curative surgery who are treated with
AZD2171 (cediranib maleate).


I. Determine the progression-free survival of patients treated with AZD2171. II. Determine
the toxicity experienced by patients treated with AZD2171. III. Determine median and overall
survival of patients treated with AZD2171.


I. Generate preliminary data regarding potential utility of pharmacogenomic and plasma/serum
biomarkers of angiogenesis as predictive or prognostic markers for future investigations of
this drug in malignant mesothelioma.

OUTLINE: This is a multicenter study.

Patients receive oral cediranib maleate once daily on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity. Patients undergo blood
collection periodically during study for biomarker and optional pharmacogenomic correlative
studies. After completion of study treatment, patients are followed for up to 8 weeks.

Inclusion Criteria:

- Histologically or cytologically confirmed malignant pleural, peritoneal, or tunica
vaginalis mesothelioma

- Epithelial, sarcomatoid, or mixed subtype

- International Mesothelioma Interest Group stage II-IV disease (for patients with
pleural mesothelioma)

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR > 10 mm by spiral CT scan

- Pleural effusion and ascites are not considered measurable lesions

- Disease not amenable to curative surgery

- No known brain metastases

- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

- Life expectancy > 3 months

- WBC ≥ 3,000/mm³

- Absolute neutrophil count ≥ 1,500/mm³

- Hemoglobin ≥ 8 g/dL

- Platelets ≥ 100,000/mm³

- Total bilirubin normal

- AST/ALT ≤ 2.5 times upper limit of normal(ULN)

- Creatinine normal OR creatinine clearance > 60 mL/min

- Fertile patients must use effective contraception

- Not pregnant or nursing

- Negative pregnancy test

- No history of allergic reactions to compounds of similar chemical or biologic
composition to AZD2171

- Mean QTc ≤ 500 msec (with Bazett's correction) by EKG

- No history of long QT syndrome

- Proteinuria ≤ 1+ on two consecutive dipsticks taken ≥ 1 week apart

- No other concurrent malignancy

- No New York Heart Association class III or IV cardiac disease

- No uncontrolled intercurrent illness including, but not limited to, any of the

- Hypertension

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situations that would limit study compliance

- No more than 1 prior cytotoxic chemotherapy

- Prior intrapleural cytotoxic agents (including bleomycin) do not count towards
prior cytotoxic chemotherapy

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
and recovered

- No prior radiotherapy to the only site of measurable disease

- At least 4 weeks since prior radiotherapy and recovered

- At least 4 weeks since prior major surgery and recovered

- More than 30 days since prior participation in an investigational trial

- No prior treatment with a vascular endothelial growth factor (VEGF) inhibitor

- No other concurrent investigational agents

- No concurrent commercial agents for the malignancy

- No concurrent medication that may markedly affect renal function (e.g., vancomycin,
amphotericin, or pentamidine)

- No concurrent hematopoietic growth factors except epoetin alfa

- No concurrent palliative radiotherapy

- No combination antiretroviral therapy for HIV-positive patients

- No concurrent drugs or biologics with proarrhythmic potential

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (complete or partial response [CR or PR]) of patients with malignant mesothelioma who are treated with cediranib maleate

Outcome Description:

Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.

Outcome Time Frame:

Every 8 weeks

Safety Issue:


Principal Investigator

Hedy Kindler

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

Related Keywords:

  • Advanced Malignant Mesothelioma
  • Epithelial Mesothelioma
  • Localized Malignant Mesothelioma
  • Recurrent Malignant Mesothelioma
  • Sarcomatous Mesothelioma
  • Mesothelioma



University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470