The Online Asbestos, Asbestos Cancer, & Mesothelioma Authority

Clinical Trials

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: Â	50
Study Start Date: Â	December 2005
Estimated Primary Completion Date: Â	October 2006 (Final data collection date for primary outcome measure)

Detailed Description:

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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 following:
  • Hypertension
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situations that would limit study compliance

PRIOR CONCURRENT THERAPY:

• 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

sarcomatous mesothelioma   advanced malignant mesothelioma   epithelial mesothelioma   recurrent malignant mesothelioma   localized malignant mesothelioma Â

Mesothelioma Adenoma Recurrence Neoplasms, Glandular and Epithelial

Neoplasms Neoplasms by Histologic Type Mesothelioma Neoplasms, Mesothelial