A Phase I Study of Hydroxychloroquine With or Without Erlotinib in Advanced NSCLC
- The goal of this study is to find the highest dose of HCQ that can be given safely with
erlotinib. Therefore, not all participants will receive the same dose of HCQ. Small
groups of participants will be enrolled in steps in this trial. The first group will
be given a certain dose of HCQ. If they have few or manageable side effects, the next
small group of participants enrolled will receive a higher dose. This increase in
doses will continue until the research doctors find the highest dose of HCQ that can be
given without causing severe or unmanageable side effects.
- Both HCQ and erlotinib are pills that are taken orally. Treatment will be divided into
time periods called cycles. Each treatment cycle is 28 days. The exception to this 28
day cycle is when participants start taking the pills for the first time. Erlotinib is
started first for 7 days and then HCQ is added. When the HCQ begins, the first cycle
of 28 days begins.
- There are several tests and procedures that will be performed at specific time periods
during protocol treatment. These include: blood work, performance status assessment,
questions about medical history and medications, tumor assessment with CT or MRI and,
- Participants may continue to receive study treatment as long as they do not experience
unacceptable side effects or disease progression.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Identify the dose limiting toxicities and maximum tolerated dose of HCQ plus erlotinib in patients with advanced NSCLC and to determine the overall safety profile.
Lecia Sequist, MD, MPH
Massachussets General Hospital
United States: Institutional Review Board
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|