PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed malignant mesothelioma of 1 of the following types:
• •* Epithelial
• •* Sarcomatoid
• •* Mixed
• •Not amenable to radiotherapy or curative surgery
• •Any site of origin including, but not limited to, the following:
• •* Pleura
• •* Peritoneum
• •* Pericardium
• •* Tunica vaginalis
• •At least one unidimensionally measurable lesion outside of prior irradiation port
• •* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• •* The following are not considered measurable:
• •* Bone lesions
• •* Leptomeningeal disease
• •* Ascites
• •* Pleural/pericardial effusion
• •* Lymphangitis cutis/pulmonis
• •* Abdominal masses that are not confirmed and followed by imaging techniques
• •* Cystic lesions
• •No known brain metastases
• •PATIENT CHARACTERISTICS:
• •Age
• •Over 18
• •Performance status
• •ECOG 0-1
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Granulocyte count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic
• •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •AST no greater than 2.5 times ULN
• •Renal
• •Creatinine no greater than 1.5 times ULN
• •Negative for proteinuria by dipstick OR
• •Urinary protein no greater than 500 mg and creatinine clearance at least 50 mL/min
• •Cardiovascular
• •No symptomatic congestive heart failure
• •No unstable angina pectoris
• •No cardiac arrhythmia
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective double-barrier contraception
• •No currently active second malignancy except non-melanoma skin cancers (unless therapy is completed and risk of relapse is less than 30%)
• •No other concurrent uncontrolled illness
• •No ongoing active infections
• •No psychiatric illness or social situation that would preclude study compliance
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No prior signal transduction inhibitor therapy
• •No prior angiogenesis inhibitor therapy
• •Chemotherapy
• •No prior cytotoxic chemotherapy for this malignancy
• •No concurrent chemotherapeutic agents
• •Prior intrapleural cytotoxic or sclerosing therapy (including bleomycin) allowed
• •Endocrine therapy
• •No concurrent hormonal therapy except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes)
• •Radiotherapy
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy
• •No concurrent palliative radiotherapy
• •Surgery
• •See Disease Characteristics
• •At least 2 weeks since prior major surgery
• •Other
• •At least 30 days since prior investigational agents
• •At least 7 days since prior grapefruit or grapefruit juice
• •At least 7 days since prior CYP3A4 inducers
• •No prior PTK787/ZK 222584
• •No prior tyrosine kinase inhibitor therapy
• •No other concurrent investigational agents
• •No concurrent isoenzyme inducers or inhibitors of p450
• •No concurrent warfarin or similar oral anticoagulants
• •* Heparin allowed
• •No concurrent grapefruit or grapefruit juice
• •No concurrent combination antiretroviral therapy for HIV-positive patients