Advanced Non Small Cell Lung Cancer, Failed Prior Chemotherapy
Conditions
Keywords
Tarceva, erlotinib, NSCLC, Non-Small Cell Lung Cancer, EGFR, OSI-774
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.
Interventions
Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash
Sponsors
OSI Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of correlating objective response rate and duration of response to grade of rash | 3 years |
Countries
United States
Outcome results
None listed