(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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Recommended phase II dose of hydroxychloroquine and carboplatin when administered with paclitaxel and bevacizumab (phase I)
Phase I portion of study
No
Joseph Aisner, MD
Principal Investigator
Cancer Institute of New Jersey
United States: Food and Drug Administration
CDR0000600241
NCT00728845
June 2008
December 2011
Name | Location |
---|---|
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |