Phase I of Bevacizumab Plus Chemotherapy in Patients With Malignant Pleural Effusion Due to Advanced Non-Small Cell Lung Cancer
The study will be conducted in patients with advanced NSCLC (stage IIIB-IV) who have MPE
requiring therapeutic drainage, and are also eligible for treatment with chemotherapy plus
bevacizumab (as defined in protocol Section 6.0). All patients will undergo placement of a
Pleur-XTM catheter as part of routine practice. Eligible patients may enroll in the
protocol prior to, or within 10 days following placement of their Pleur-XTM catheter. Upon
enrollment, patients will be given a logsheet on which to record the volume of pleural fluid
drained from their catheter. Only patients who, in the opinion of the treating physician,
do not have a hemorrhagic pleural effusion (grossly bloody, or pleural fluid hemoglobin
concentration > 25% of blood hemoglobin concentration) may remain on study. In addition,
only patients who, in the opinion of the treating physician, have satisfactory placement of
their Pleur-XTM catheter may remain on study.
Approximately 15 patients will be enrolled with the goal to treat 10 patients with
chemotherapy plus bevacizumab. The additional enrollments will be necessary in that it is
estimated that approximately 1 in 3 patients will be taken off study due to failure of
Pleur-XTM catheter placement, or discovery of hemorrhagic effusion.
Patients who remain on study will begin chemotherapy. All eligible patients will receive
bevacizumab 15mg/kg IV x 1 dose as a single agent. Three weeks later, chemotherapy will be
initiated according to routine clinical practice along with continued use of bevacizumab.
Acceptable chemotherapy regimens for this protocol are detailed in Section 5.0 of the
protocol. Only the administration of bevacizumab will be governed by the protocol (Section
11.0). Dose reductions of all other drugs will be made according to routine clinical
practice. Pleural fluid will be drained from the Pleur-XTM at least every other day (qod),
and volume recorded by the patient in a log book. Pleur-XTM catheters may be removed when
pleural symphysis is achieved (defined in Section 12.0), or at the discretion of the
treating physician. The schedule of follow-up visits may vary according to the chemotherapy
regimen, however all patients must be evaluated in the clinic at least every 3 weeks with a
doctor visit to record drainage volume, and status of their Pleur-XTM catheter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety and feasibility of administering chemotherapy plus bevacizumab to patients with metastatic NSCLC and MPE following insertion of a Pleur-XTM catheter.
end of study
Christopher G. Azzoli, M.D.
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
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