Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma

Inclusion Criteria

• •Patients must have histologically confirmed malignant pleural or peritoneal mesothelioma epithelial, sarcomatoid, or mixed subtype, not amenable to curative treatment with surgery. Patients with pleural mesothelioma will be clinically staged using the International Mesothelioma Interest Group staging criteria. Note that there is no staging system for peritoneal mesothelioma and those patients will only be followed for survival. Patients may be entered based on local pathology.
• •Disease status must be that of measurable disease as defined by modified Southwest Oncology Group (SWOG) criteria.
• •* Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology.
• •* Measurable lesions: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20 mm using conventional techniques or ≥10 mm using spiral computerized tomography (CT) scans. At least one level must have one rind measurement ≥15 mm.
• •CT (specifically spiral CT) scans and magnetic resonance imaging (MRI) are the preferred methods of measurement.
• •Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes).
• •For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required.
• •NOTE: Neither pleural effusions nor positive bone scans are considered measurable.
• •Patients may have undergone pleurodesis. If pleurodesis was performed, there must be at least a 2-week delay before Oxaliplatin or gemcitabine is administered. If the original CT scan occurred prior to the pleurodesis, an additional CT scan is required 2 weeks or longer after the pleurodesis, which will then be considered the baseline scan.
• •NOTE: For patients with clinically significant pleural effusions or ascites, consideration should be given to draining the fluid.
• •Performance status of 0, 1 or 2 on Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (after any palliative measures including pleural drainage have occurred).
• •Estimated life expectancy of at least 12 weeks.