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.
Brief Title
OSI-774 (Erlotinib, Tarceva) in Elderly Patients
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).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Non-Small Cell Lung Cancer
Eligibility Criteria
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.
* 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.
Inclusion Criteria
Inclusion Criteria:
* Patients must have confirmed non-small cell lung cancer. Age \> 65 years Patients must have adequate organ and marrow function
* Patients must have confirmed non-small cell lung cancer. Age \> 65 years Patients must have adequate organ and marrow function
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
65 Years
NCT Id
NCT00200395
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
03-01-019
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC)
Primary Outcomes
Outcome Description
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.
Outcome Measure
Rate of Response
Outcome Time Frame
1-3 years
Secondary Outcomes
Outcome Time Frame
1-3 years
Outcome Measure
Number of participants with treatment-related adverse events as assessed by CTCAE v2.0
Outcome Description
This will involve participant response to a seven-item lung cancer subscale of Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire.
Outcome Time Frame
through study completion, an average of 3 years
Outcome Measure
Changes in Quality of Life (QOL): questionnaire
Outcome Description
Progression free survival is defined as the duration of time from start of treatment to time of progression.
Outcome Time Frame
1-3 years
Outcome Measure
Rate of Progression free survival
Outcome Description
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.
Outcome Time Frame
1-3 years
Outcome Measure
Duration of stable disease
Outcome Time Frame
Up to 5 years
Outcome Measure
Overall Rate of Survival
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
65
Investigators
Investigator Type
Principal Investigator
Investigator Name
Lakshmi Rajdev
Investigator Email
lrajdev@montefiore.org
Investigator Phone