Clinical trial · Interventional
Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients
A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT00137800CI-TRIAL-00044462completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OSI-774 (Tarceva) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tarceva
- description
- Chemotherapy Single Agent Systemic
- interventionNames
- Drug: OSI-774 (Tarceva)
Primary outcomes (2)
- measure
- To determine how well non-small cell lung cancer cells in the body respond to OSI-774
- timeFrame
- 2 years
- measure
- To determine the survival rate of patients treated with OSI-774
Secondary outcomes (2)
- measure
- To determine the safety of OSI-774 in people 70 years of age or older
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDShepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753. PMID 16014882
- BACKGROUNDPerez-Soler R, Chachoua A, Hammond LA, Rowinsky EK, Huberman M, Karp D, Rigas J, Clark GM, Santabarbara P, Bonomi P. Determinants of tumor response and survival with erlotinib in patients with non--small-cell lung cancer. J Clin Oncol. 2004 Aug 15;22(16):3238-47. doi: 10.1200/JCO.2004.11.057. PMID 15310767