Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma
Condition: Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: bevacizumab; cisplatin; pemetrexed
Intervention description: 15 mg/kg IV every 3 weeks; 75 mg/m2 IV every 3 weeks; 500 mg/m2 every 3 weeks
Intervention MeSH terms: Bevacizumab; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mesothelioma; bevacizumab; chemotherapy

Summary:

      To estimate the time to progression of cancer in patients with previously untreated
      mesothelioma receiving cisplatin, pemetrexed and bevacizumab
    

Eligibility criteria:

        Inclusion criteria

        5.2.1 Patients must have histologically proven malignant mesothelioma (epithelial,
        sarcomatoid, or mixed subtype) not amenable to curative surgery or radiotherapy. Eligible
        sites of origin include the pleura, peritoneum, and tunica vaginalis.

        5.2.2 Patient's disease must not be amenable to curative treatment with surgery. Evidence
        of gross unresectability will include but not be limited to direct extension into the chest
        wall, mediastinal or hilar lymphadenopathy, pulmonary or cardiac function that is
        inadequate to tolerate resection, and sarcomatoid or mixed histology.

        5.2.3 Patients must be > 18 years old 5.2.4 Patients must have measurable disease.

        Adequate organ function and functional status

        Exclusion Criteria:

        a. General Medical Concerns 5.3.1 Patients must not be pregnant or breast feeding. 5.3.2 No
        "currently active" second malignancy other than non-melanoma skin cancer. Patients are not
        considered to have a "currently active" second malignancy if they have completed therapy
        and have a less than 30% risk of relapse.

        5.3.3 No uncontrolled intercurrent illness including but not limited to: active infection,
        symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or
        psychiatric/social situations that would limit compliance with study requirements.

        5.3.4 No HIV positive patients receiving combination anti-retroviral therapy because of
        possible pharmacokinetic interactions with study medications.

        5.3.5 History of allergic reactions attributed to compounds of similar chemical or biologic
        composition to bevacizumab or other agents used in the study.

        5.3.6 Inability to interrupt aspirin or other non-steroidal medication for a 5 day period.

        c. Bevacizumab-Specific Concerns

        Subjects meeting any of the following criteria are ineligible for study entry:

        5.3.7 Patients with brain metastases are excluded 5.3.8 History of myocardial infarction or
        CVA (stroke) within 6 months of study entry.

        5.3.9 Evidence of bleeding diathesis or coagulopathy. Patients on therapeutic doses of
        coumadin are eligible as long as the INR is maintained in the range of 2-3 and there is no
        evidence of active bleeding.

        5.3.10 Major surgical procedure, open biopsy, or significant traumatic injury within 28
        days prior to Day 0, anticipation of need for major surgical procedure during the course of
        the study 5.3.11 Urine protein:creatinine ratio less than 1.0 at screening 5.3.12 Serious,
        non-healing wound, ulcer, or bone fracture