OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT00230126
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • erlotinib — DRUG
    Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.

Study Details

This study determines tumor response rate, time to tumor progression and survival rate at 1 year produced by OSI-774 in previously treated African American patients with nonsmall cell lung cancer.

Key Dates

First listed
Sep 30, 2005
Start date
Oct 31, 2005
Status verified
Nov 2017
Primary completion
Sep 30, 2011
Completion
Jul 31, 2013

Study Design

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

Arms

  • Active Comparator: A erlotinib 150 mg
    erlotinib 150 mg/day cycles 1 - 3
  • Experimental: B erlotinib modified according to weight
    erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.

Primary Outcome Measure

Disease Control Rate at 12 Weeks [ Time Frame: 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State UniversityColumbusOhio43210-

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By research site
Ohio State University· Columbus, OH

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