Completed

A Phase I Study of Erlotinib in Combination With Quinacrine in Patients With Advanced Non-Small-Cell Lung Cancer

What is being tested

erlotinib hydrochloride

+ quinacrine dihydrochloride - Escalation dose

+ laboratory biomarker analysis

DrugOther

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

Over 18 Years

+30 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: September 2013

See protocol details

Summary

Principal SponsorNeelesh Sharma MD PhD

Last updated: October 31, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2013

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of the combination of erlotinib (erlotinib hydrochloride) and quinacrine (quinacrine dihydrochloride) in patients with advanced non-small-cell lung cancer. II. To determine the recommended Maximum Tolerated Dose (MTD) of the combination of erlotinib and quinacrine in patients with advanced non-small-cell lung cancer. SECONDARY OBJECTIVES: I. To describe the dose limiting toxicity of the erlotinib and quinacrine combination. II. To determine the pharmacokinetic profile of the erlotinib and quinacrine combination. III. To determine objective response rate (complete response [CR]+partial response [PR]) and clinical benefit rate (CR+PR+ stable disease [SD]) of the erlotinib and quinacrine combination. IV. To estimate overall survival (OS) OUTLINE: This is a phase I, dose escalation study of quinacrine dihydrochloride Escalation Portion: Patients receive erlotinib hydrochloride orally (PO)daily on days 1-28 and quinacrine dihydrochloride PO thrice daily (TID) on days, 1-7 and PO daily from days 8-28. After Maximum Tolerated Dose is established: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive erlotinib hydrochloride PO daily on days 1-28. ARM II: Patients receive erlotinib hydrochloride PO and quinacrine dihydrochloride PO daily (TID) on days, 1-7 and PO daily from days 8-28. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

NCT01839955

Principal SponsorNeelesh Sharma MD PhD

Last updated: October 31, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsCarcinoma, Non-Small-Cell Lung

Criteria

16 inclusion criteria required to participate

Absolute neutrophil count (ANC) >= 1,500/mcL

Alkaline phosphatase < 2.5 X institutional upper limit of normal (in subjects with no liver metastasis and < 5.0 upper limit of normal [ULN] in subjects with liver metastasis)

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal (in subjects with no liver metastasis and < 5.0 ULN in subjects with liver metastasis)

Eastern Cooperative Oncology Group (ECOG) performance status <= 2

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14 exclusion criteria prevent from participating

Any other condition that is unstable or which could jeopardize the safety of the patient and his/her protocol compliance

History of cardiac disease: congestive heart failure defined as class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); previously diagnosed bradycardia or other cardiac arrhythmia defined as >= grade 2 according to NCI-CTCAE (version 4.0), or uncontrolled hypertension; myocardial infarction occurred within 6 months prior to study entry (myocardial infarction occurred > 6 months prior to study entry is permitted)

History of incurable malignancy other than NSCLC within the 5 years prior to start of treatment, with the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri; prostate carcinoma with a prostate-specific antigen value < 0.2 ng/mL; or basal or squamous-cell carcinoma of the skin

Patients that have had major surgery <= 3 weeks or minor surgery (e.g. talc pleurodesis, excisional biopsy, etc) <= 1 week prior to the first day of study defined treatment

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Erlotinib hydrochloride and quinacrine dihydrochloride. The first three or six patients will be entered in this part of the study. Then this part will end.

Group II

Experimental

Erlotinib hydrochloride and quinacrine dihydrochloride. The next 12 patients will enter into the second part of this study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer

Cleveland, United StatesOpen University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer in Google Maps

CompletedOne Study Center