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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Neelesh Sharma MD PhD
Study ID
NCT01839955
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
    Dose Escalation Group: Begins day 1: given 150mg daily, orally Extension Group: Begins Day 1: 150mg daily, orally
  • quinacrine dihydrochloride - Escalation dose — DRUG
    Begins 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
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies
  • quinacrine dihydrochloride - Extension dose — DRUG
    Participants will be treated at recommended dose from expansion group to confirm tolerability and evaluate early response

Study Details

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

Key Dates

First listed
Apr 25, 2013
Start date
Sep 30, 2013
Status verified
Oct 2016
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (Dose Escalation Group)
    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.
  • Experimental: Arm II (Extension Group)
    Erlotinib hydrochloride and quinacrine dihydrochloride. The next 12 patients will enter into the second part of this study.

Primary Outcome Measure

Maximum tolerated dose (MTD) of quinacrine dihydrochloride in combination of erlotinib hydrochloride determined by dose-limiting toxicities [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive CancerClevelandOhio44106-

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By research site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer· Cleveland, OH

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