Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 29, 2005 | ||||
| Last Updated Date | April 5, 2013 | ||||
| Start Date ICMJE | February 2003 | ||||
| Primary Completion Date | May 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE |
|
||||
| Change History | Complete list of historical versions of study NCT00137800 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients | ||||
| Official Title ICMJE | A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC) | ||||
| Brief Summary | 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. |
||||
| Detailed Description | 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Non-Small-Cell Lung Carcinoma | ||||
| Intervention ICMJE | Drug: OSI-774 (Tarceva)
Once daily without interruption as long as there is no disease progression or serious side effects experienced. |
||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | December 2013 | ||||
| Primary Completion Date | May 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 70 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00137800 | ||||
| Other Study ID Numbers ICMJE | 02-308 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute | ||||
| Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||
| Collaborators ICMJE |
|
||||
| Investigators ICMJE |
|
||||
| Information Provided By | Dana-Farber Cancer Institute | ||||
| Verification Date | April 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||