500 Boylston Street, Boston, MA 02116 617-419-4700
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RATIONALE: 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.
PURPOSE: This phase II trial is study how well AZD2171 works in treating patients with
malignant pleural mesothelioma that cannot be removed by surgery.
Ages:18 and older
DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - WBC ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - AST or ALT ≤ 1.5 times upper limit of normal (ULN) - Bilirubin normal Renal - Creatinine ≤ 1.5 times ULN OR - Creatinine clearance ≥ 50 mL/min - Proteinuria ≤ 1+ by 2 consecutive dipstick tests taken ≥ 1 week apart Cardiovascular - 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 Gastrointestinal - 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 Other - 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 CONCURRENT THERAPY: 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 Chemotherapy - See Disease Characteristics - No more than 1 prior chemotherapy regimen - At least 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin) and recovered Radiotherapy - At least 21 days since prior radiotherapy and recovered Surgery - See Disease Characteristics - At least 28 days since prior major surgery (e.g., thoracotomy or laparotomy) and recovered - No prior surgery that would affect absorption Other - 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
Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00243074
Not Accepting Healthy Volunteers