Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Malignant Mesothelioma

Completed · Phase 2 · Has a placebo group

Conditions studied: Advanced Malignant Mesothelioma, Epithelial Mesothelioma, Localized Malignant Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma

In brief

This randomized phase II trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have malignant mesothelioma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known if combination chemotherapy works better with or without bevacizumab in treating malignant mesothelioma.

Key facts

Study ID

NCT00027703

Run by

National Cancer Institute (NCI)

People needed

106

Starts

2001-10-01

Last updated by the study team

2014-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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