Clinical Trials Directory

Trials / Completed

CompletedNCT01839955

Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Neelesh Sharma MD PhD · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and best dose of quinacrine dihydrochloride when given together with erlotinib hydrochloride and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as quinacrine dihydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib hydrochloride together with quinacrine dihydrochloride may kill more tumor cells

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGerlotinib hydrochlorideDose Escalation Group: Begins day 1: given 150mg daily, orally Extension Group: Begins Day 1: 150mg daily, orally
DRUGquinacrine dihydrochloride - Escalation doseBegins Day 8: Loading dose (first cycle only) 50mg three times daily for 7 days followed by 21 days of 50mg maintenance dose. Level -1: Loading dose (50mg three times daily for 7 days), maintenance dose (50mg every other day for three weeks). Level 1 \[starting dose\]: Loading dose (50mg three times daily for 7 days), maintenance dose (50mg daily for three weeks). Level 2: Loading dose (100mg three times daily for 7 days), maintenance dose (100mg every other day for three weeks). Level 3: Loading dose (150mg three times daily for 7 days), maintenance dose (200mg every other day for three weeks). Level 4: Loading dose (200mg three times daily for 7 days), maintenance dose (400mg every other day for three weeks). Subsequent patient cohort(s) will be enrolled depending on the safety and tolerability of subjects
OTHERlaboratory biomarker analysisCorrelative studies
OTHERpharmacological studyCorrelative studies
DRUGquinacrine dihydrochloride - Extension doseParticipants will be treated at recommended dose from expansion group to confirm tolerability and evaluate early response

Timeline

Start date
2013-09-01
Primary completion
2016-10-01
Completion
2016-10-01
First posted
2013-04-25
Last updated
2016-10-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01839955. Inclusion in this directory is not an endorsement.