Lung Cancer Clinical Trial
Official title:
(NJ 1508) Modulation of Autophagy With Hydroxychloroquine in Combination With Carboplatin, Paclitaxel and Bevacizumab in Patients With Advanced/Recurrent Non-Small Cell Lung Cancer - A Phase I/II Study
RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, carboplatin, and
paclitaxel and work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can
block tumor growth in different ways. Some block the ability of tumor cells to grow and
spread. Others find tumor cells and help kill them or carry tumor-killing substances to
them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the
tumor. Giving hydroxychloroquine together with carboplatin, paclitaxel and bevacizumab may
kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of
hydroxychloroquine when given together with carboplatin, paclitaxel, and bevacizumab and to
see how well they work in treating patients with recurrent advanced non-small cell lung
cancer.
OBJECTIVES:
Primary
- To determine the recommended phase II dose of hydroxychloroquine and carboplatin in
combination with paclitaxel and bevacizumab in patients with advanced recurrent
non-small cell lung cancer. (Phase I)
- To assess the antitumor activity, as measured by tumor response rate, of this regimen
in these patients. (Phase II)
Secondary
- To measure time to progression, progression-free survival, and overall survival of
these patients.
- To assess the incidence of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. This is a phase I, dose-escalation study of
carboplatin and hydroxychloroquine followed by a phase II study.
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and
bevacizumab IV over 90 minutes on day 1 and oral hydroxychloroquine on days 1-21. Treatment
repeats every 21 days for a total of 4 courses. Patients then receive bevacizumab IV over
30-90 minutes every 21 days and oral hydroxychloroquine daily for up to 1 year in the
absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 6 months.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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