NCT02881125

Paclitaxel and Nortriptyline Hydrochloride in Treating Patients With Relapsed Small Cell Carcinoma

A Phase 1 Study of Weekly Paclitaxel and Nortriptyline for Relapsed Small Cell Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Small Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nortriptyline Hydrochloride	Given PO
DRUG	Paclitaxel	Given IV

Timeline

• Start date: 2016-11-03
• Primary completion: 2018-01-01
• Completion: 2019-11-30
• First posted: 2016-08-26
• Last updated: 2019-12-17

Locations

1 site across 1 country: United States