Small Cell Carcinoma Clinical Trial
Official title:
A Phase 1 Study of Weekly Paclitaxel and Nortriptyline for Relapsed Small Cell Carcinoma
This phase I trial studies the side effects and best dose of nortriptyline hydrochloride when given together with paclitaxel in treating patients with small cell carcinoma that has come back. Nortriptyline hydrochloride, may help disrupt survival signals and cause cancer cell death. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nortriptyline hydrochloride and paclitaxel may work better in treating patients with small cell carcinoma.
PRIMARY OBJECTIVES:
I. To determine the maximally tolerated dose (MTD) of nortriptyline hydrochloride
(nortriptyline) combined with weekly paclitaxel (PC).
SECONDARY OBJECTIVES:
I. To assess the overall response rate (ORR) to nortriptyline combined with PC.
II. To assess progression free survival (PFS) and overall survival (OS).
OUTLINE: This is a dose-escalation study of nortriptyline hydrochloride.
Patients receive paclitaxel intravenously (IV) on days 1, 8, and 15. Patients also receive
nortriptyline hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on
days 8-14, and thrice daily (TID) on days 15-28 of course 1 and TID on days 1-28 of
subsequent courses. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days and every 3 months
for 2 years.
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