Back to resultsErlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer
Primary Purpose
Advanced Non Small Cell Lung Cancer, Failed Prior Chemotherapy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tarceva (Trademark) (erlotinib HCl, OSI-774)
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Non Small Cell Lung Cancer focused on measuring Tarceva, erlotinib, NSCLC, Non-Small Cell Lung Cancer, EGFR, OSI-774
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological). Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer. Measurable disease per RECIST criteria. Adequate bone marrow, hepatic and renal function. Exclusion Criteria: Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years. Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days. Known hypersensitivity to minocycline. History of serious cardiac disease that is not controlled. Serious eye conditions. Prior treatment with inhibitors of EGFR of any kind.
Sites / Locations
- Institute for Drug Development Cancer Therapy and Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1 erlotinib
Arm Description
Outcomes
Primary Outcome Measures
Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate
Secondary Outcome Measures
Feasibility of correlating objective response rate and duration of response to grade of rash
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00072631
Brief Title
Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer
Official Title
A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 5, 2003 (Actual)
Primary Completion Date
March 14, 2007 (Actual)
Study Completion Date
March 14, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OSI Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.
Detailed Description
Only patients with 0 to 1 performance status on the ECOG scale are eligible.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non Small Cell Lung Cancer, Failed Prior Chemotherapy
Keywords
Tarceva, erlotinib, NSCLC, Non-Small Cell Lung Cancer, EGFR, OSI-774
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 erlotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tarceva (Trademark) (erlotinib HCl, OSI-774)
Intervention Description
Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash
Primary Outcome Measure Information:
Title
Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Feasibility of correlating objective response rate and duration of response to grade of rash
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
Measurable disease per RECIST criteria.
Adequate bone marrow, hepatic and renal function.
Exclusion Criteria:
Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
Known hypersensitivity to minocycline.
History of serious cardiac disease that is not controlled.
Serious eye conditions.
Prior treatment with inhibitors of EGFR of any kind.
Facility Information:
Facility Name
Institute for Drug Development Cancer Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=56
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer
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