Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 70 - Any |
| Updated: | 3/28/2019 |
| Start Date: | February 2003 |
| End Date: | December 2020 |
A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and
potentially as good as or better than standard chemotherapy drugs, when given to subjects
with non-small cell lung cancer, who are 70 years of age or older.
potentially as good as or better than standard chemotherapy drugs, when given to subjects
with non-small cell lung cancer, who are 70 years of age or older.
Patients will receive OSI-774 once daily without interruption. There are no pre-determined
number of cycles or planned dose interruptions. For the purposes of evaluation, toxicity and
efficacy, a four week (28 day period) will be considered 1 cycle.
Patients will continue to receive OSI-774 until they develop progressive disease,
unacceptable side-effects or wish to withdraw from the study.
Patients will have radiographic evaluations after every two cycles of therapy. After cycle 2,
patients will also be evaluated by FDG-PET scanning.
Patients will also be asked to fill out a Lung Cancer Symptom Scale (LCSS) on the first day
of each cycle.
Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study.
number of cycles or planned dose interruptions. For the purposes of evaluation, toxicity and
efficacy, a four week (28 day period) will be considered 1 cycle.
Patients will continue to receive OSI-774 until they develop progressive disease,
unacceptable side-effects or wish to withdraw from the study.
Patients will have radiographic evaluations after every two cycles of therapy. After cycle 2,
patients will also be evaluated by FDG-PET scanning.
Patients will also be asked to fill out a Lung Cancer Symptom Scale (LCSS) on the first day
of each cycle.
Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study.
Inclusion Criteria:
- Age: 70 years of age or older
- Stage IV or IIIB non-small cell lung cancer (NSCLC)
- Measurable tumor(s)
- Three or more weeks since prior radiation therapy
- Three or more weeks since prior major surgery
- Must at least be able to walk and capable of taking care of oneself although unable to
carry out work activities.
- Must be up and about more than 50% of waking hours.
- Life expectancy of 8 weeks or more
- Blood tests that show kidneys, liver and bone marrow to be working adequately
- Completely healed from previous oncologic or other major surgery
Exclusion Criteria:
- Prior chemotherapy regimen for non-small cell lung cancer
- Prior exposure to OSI-774 or similar treatments such as trastuzumab, ZD1839, C225,
etc.
- Uncontrolled central nervous system metastases
- Concurrent active cancer
- Malignancies within the past 5 years except for adequately treated carcinoma of the
cervix or basal or squamous cell carcinomas of the skin
- Prior chemotherapy for any malignant disease
- Difficulty swallowing
- A disease or disorder that interferes with ability to digest and absorb food
- A medical condition that could make it unsafe for patient to participate in this study
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