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
3 other identifiers
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2016
CompletedFirst Posted
Study publicly available on registry
August 26, 2016
CompletedStudy Start
First participant enrolled
November 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedDecember 17, 2019
December 1, 2019
1.2 years
August 23, 2016
December 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose, determined by the number of patients who experience a dose limiting toxicity
Maximum tolerated dose 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 evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Up to 28 days
Secondary Outcomes (3)
Objective tumor response evaluated according to Response Evaluation Criteria in Solid Tumors version 1.1
Up to 2 years
Overall Survival
Up to 2 years
Progression free survival
Up to 2 years
Study Arms (1)
Treatment (paclitaxel, nortriptyline hydrochloride)
EXPERIMENTALPatients receive paclitaxel IV on days 1, 8, and 15. Patients also receive nortriptyline hydrochloride PO QD on days 1-7, BID on days 8-14, and 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.
Interventions
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- Ability to understand and the willingness to sign a written informed consent
- Pathologically-confirmed small cell carcinoma of any primary site
- Relapse following platinum-based chemotherapy or documented progressive disease while on platinum-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 at time of informed consent
- Absolute neutrophil count \>= 1.5 x 10\^9 cells/L
- Hemoglobin (Hgb) \>= 9.0 g/dL
- Platelets \>= 100,000 x 10\^9/L
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
- Alkaline phosphatase levels =\< 2.5 x upper limit of normal (ULN)
- Total bilirubin =\< 1.5 x ULN
- Serum creatinine \< 1.5 mg/dL
- At least one site of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on computed tomography (CT) scan done within 30 days prior to study start
- Women of child-bearing potential and sexually active men must agree to use adequate contraception (hormonal, barrier method, or abstinence) prior to study entry, during treatment, and for three months after completing treatment
- Baseline electrocardiogram demonstrating all of the following: corrected QT (QTc) \< 450 milliseconds (msec) (men) and \< 470 msec (women), PR \< 240 msec, QRS \< 100 msec
You may not qualify if:
- Untreated active major depression
- Bipolar disorder
- Pregnancy and lactation; refusal to use adequate contraception
- History of seizures in the past 3 years
- Concurrent therapy with monoamine oxidase inhibitors (MAOI), selective serotonin reuptake inhibitors (SSRI), or other tricyclic antidepressants (TCA) or use within 2 weeks study start
- Concomitant therapy with any drugs shown to have major interactions with nortriptyline (i.e. known inhibitors of cytochrome P450 family 2 subfamily D member 6 \[CYP2D6\]) and use during the 30-day period prior to study start
- Myocardial infarction in preceding 4 weeks; history of uncontrolled cardiac arrhythmias or family history of sudden cardiac death
- Peripheral neuropathy grade 2 or greater
- Progressive or symptomatic central nervous system (CNS) metastases; patients with known brain metastasis must have stable disease following treatment surgery, radiation, or both
- Glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Montgomery
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2016
First Posted
August 26, 2016
Study Start
November 3, 2016
Primary Completion
January 1, 2018
Study Completion
November 30, 2019
Last Updated
December 17, 2019
Record last verified: 2019-12