Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma
Condition: Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: Oxaliplatin; Gemcitabine
Intervention description: Oxaliplatin 100 mg/m2 IV infusion for 2 hours; Gemcitabine 1000mg/m2 IV infusion for 90 minutes
Intervention MeSH terms: Gemcitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mesothelioma

Summary:

      In patients with pleural or peritoneal mesothelioma, what is the response rate to combined
      Oxaliplatin (ELOXATIN®) and Gemcitabine chemotherapy?
    

Eligibility criteria:

        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.

        Exclusion Criteria:

          -  More than one previous regimen of systemic chemotherapy. Prior intracavitary cytotoxic
             drugs will count as a prior regimen, unless given for the purpose of pleurodesis.
             Immunomodulators will not be regarded as chemotherapy. Prior systemic treatment with
             pemetrexed plus a platinum compound will not be a contraindication for
             gemcitabine-oxaliplatin.

          -  Prior radiation therapy to the target lesion, unless the lesion is clearly progressing
             and the interval between the most recent radiation therapy and enrollment is at least
             4 weeks.

          -  Active infection (at the discretion of the investigator).

          -  Pregnancy or breast feeding.

          -  Serious concomitant systemic disorders (including oncologic emergencies) incompatible
             with the study (at the discretion of the investigator).

          -  Patients with a "currently active" second malignancy other than non-melanoma skin
             cancer or carcinoma in situ of the cervix are not to be registered. Patients who are
             not considered to have a "currently active" malignancy if they have completed therapy
             and are considered by their physician to be at less than 30% risk of relapse.

          -  Use of any investigational agent within 4 weeks before enrollment into the study.

          -  Disease which cannot be radiologically imaged.