Paclitaxel and Nortriptyline Hydrochloride in Treating Patients With Relapsed Small Cell Carcinoma
NCT ID: NCT02881125
Last Updated: 2019-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
2 participants
INTERVENTIONAL
2016-11-03
2019-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (paclitaxel, nortriptyline hydrochloride)
Patients 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.
Nortriptyline Hydrochloride
Given PO
Paclitaxel
Given IV
Interventions
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Nortriptyline Hydrochloride
Given PO
Paclitaxel
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Robert Montgomery
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2016-01197
Identifier Type: REGISTRY
Identifier Source: secondary_id
9618
Identifier Type: OTHER
Identifier Source: secondary_id
9618
Identifier Type: -
Identifier Source: org_study_id