OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer
A Phase II Randomized Study of OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer (NSCLC)
2 other identifiers
interventional
57
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2005
CompletedFirst Posted
Study publicly available on registry
September 30, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
November 7, 2014
CompletedDecember 26, 2017
November 1, 2017
5.9 years
September 28, 2005
April 15, 2014
November 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Disease Control Rate at 12 Weeks
no progression of disease at 12 weeks from starting treatment
12 weeks
Time to Progression
Every 12 weeks
1-year Survival Rate
12 months
Study Arms (2)
A erlotinib 150 mg
ACTIVE COMPARATORerlotinib 150 mg/day cycles 1 - 3
B erlotinib modified according to weight
EXPERIMENTALerlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Must have histologically or cytologically confirmed stage IIIB or IV NSCLC treated with 1-2 platinum- or taxane-containing regimens
- Measurable disease
- May have had prior surgery \& external beam radiation
- African American
- years or older
You may not qualify if:
- Known brain mets
- Prior treatment with EGFR targeting therapies
- Pregnant/lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State University Comprehensive Cancer Centerlead
- Genentech, Inc.collaborator
Study Sites (1)
Ohio State University
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Miguel Villalona
- Organization
- The Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel Villalona, M.D.
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2005
First Posted
September 30, 2005
Study Start
October 1, 2005
Primary Completion
September 1, 2011
Study Completion
July 1, 2013
Last Updated
December 26, 2017
Results First Posted
November 7, 2014
Record last verified: 2017-11