Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma
Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Localized Malignant Mesothelioma
About this trial
This is an interventional treatment trial for Advanced Malignant Mesothelioma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma that is not amenable to curative surgery Epithelial, sarcomatoid, or mixed subtype Evidence of gross unresectability, including, but not limited to, the following conditions: Direct extension into the chest wall Mediastinal or hilar lymphadenopathy Pulmonary or cardiac function that is inadequate to tolerate resection Sarcomatoid or mixed histology Pleural mesothelioma must be stage II or greater using the International Mesothelioma Interest Group staging system Measurable disease outside prior irradiation port At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Pleural effusions and ascites are not considered measurable lesions Site in pleura, lung, liver, or retroperitoneum that can be assessed by MRI for evaluation of blood flow No obvious tumor involvement of major vessels by CT scan No known brain metastases Performance status - ECOG 0-1 More than 3 months WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No history of bleeding diathesis Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal INR no greater than 1.5 Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min If 1+ or greater proteinuria on dipstick, then must have less than 500 mg of protein/24-hour urine collection No significant renal impairment See Disease Characteristics No history deep vein thrombosis No myocardial ischemia or infarction within the past 6 months No uncompensated coronary artery disease within the past 6 months No uncontrolled hypertension No symptomatic congestive heart failure No unstable angina pectoris within the past 6 months No cardiac arrhythmia No transient ischemic attack within the past 6 months No cerebrovascular accident within the past 6 months No other arterial thromboembolic event within the past 6 months No clinically significant peripheral artery disease See Disease Characteristics No history of pulmonary embolism No prior allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other study agents No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No ongoing or active infection No other concurrent uncontrolled illness that would preclude study participation No psychiatric illness or social situations that would preclude compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No growth factors for 24 hours before, during, or for 24 hours after cytotoxic chemotherapy See Biologic therapy Prior intrapleural cytotoxic agents (including bleomycin) allowed No prior systemic cytotoxic chemotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered See Disease Characteristics At least 6 weeks since prior major surgery At least 30 days since prior investigational drug No other concurrent investigational or commercial agents or therapies No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-60 minutes (beginning after gemcitabine infusion) and bevacizumab IV over 30-90 minutes (beginning after cisplatin infusion) on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD), complete response (CR), or partial response (PR) after the sixth course may receive bevacizumab as a single agent once every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive gemcitabine and cisplatin as in arm I and placebo IV over 30-90 minutes (beginning after cisplatin infusion) on day 1. Treatment repeats as in arm I. Patients who achieve SD, CR, or PR after the sixth course may receive placebo as a single agent once every 3 weeks in the absence of disease progression.