Non-Small Cell Lung Cancer
Conditions
Brief summary
The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. The investigators would also like to estimate disease-related symptom improvement rates using a questionnaire.
Detailed description
In recent years, it has been shown that the degree of improvement achievable with chemotherapy has plateaued with the use of chemotherapy doublets. The presence of co-morbid conditions and poor performance status may preclude the use of chemotherapy in many elderly patients, which even in the medically fit, has modest benefits. The advent of targeted cancer therapy with the discovery of tyrosine kinases as mediators of tumor growth, with its limited toxicity profile, offers a promising approach to the treatment of NSCLC, in particular to the elderly subset of patients. The encouraging results from the other trials provide a strong rationale to evaluate an oral EGFR-tyrosine kinase inhibitor OSI-774 in patients with advanced and inoperable NSCLC over the age of 70. In vitro and clinical data suggest a dose- dependent response with Tarceva (Genentech, data on file).
Interventions
DRUGTarceva
OSI-774 will be supplied as 25 mg (non -film coated) 100 and 150 mg (film coated) tablets in separate bottles, containing 30 tablets respectively.
Sponsors
Genentech, Inc.
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have confirmed non-small cell lung cancer. Age \> 65 years Patients must have adequate organ and marrow function
Exclusion criteria
* Patients who have had prior chemotherapy will be excluded. Patients may not be receiving any other investigational agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Response | 1-3 years | The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date the recurrent or progressive disease is documented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v2.0 | 1-3 years | — |
| Changes in Quality of Life (QOL): questionnaire | through study completion, an average of 3 years | This will involve participant response to a seven-item lung cancer subscale of Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. |
| Rate of Progression free survival | 1-3 years | Progression free survival is defined as the duration of time from start of treatment to time of progression. |
| Duration of stable disease | 1-3 years | Stable disease is measured from the start of the treatment until the criteris for progression are met., taking as reference the smallest measurements recorded since the treatment started. |
| Overall Rate of Survival | Up to 5 years | — |
Countries
United States
Outcome results
None listed