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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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) of nortriptyline combined with weekly 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.


Sponsor: University of Washington

Current Primary Outcome: Maximum tolerated dose (MTD), determined by the number of patients who experience a dose limiting toxicity (DLT) [ Time Frame: Up to 28 days ]

MTD defined as the highest dose level of nortriptyline (in combination with weekly paclitaxel) where < 1/3 or < 2/6 patients experience a dose-limiting toxicity (DLT) evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Objective tumor response evaluated according to RECIST criteria version 1.1 [ Time Frame: Up to 2 years ]
    Objective tumor response will be assessed with a 95% confidence interval.
  • Overall Survival (OS) [ Time Frame: Up to 2 years ]
    OS will be described using Kaplan-Meier curves.
  • Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]
    PFS will be described using Kaplan-Meier curves.


Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: August 23, 2016
Date Started: November 2016
Date Completion:
Last Updated: January 11, 2017
Last Verified: January 2017