Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00137800|
Recruitment Status : Active, not recruiting
First Posted : August 30, 2005
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Carcinoma||Drug: OSI-774 (Tarceva)||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||May 2005|
|Estimated Study Completion Date :||December 2016|
- Drug: OSI-774 (Tarceva)
Once daily without interruption as long as there is no disease progression or serious side effects experienced.
- To determine how well non-small cell lung cancer cells in the body respond to OSI-774 [ Time Frame: 2 years ]
- To determine the survival rate of patients treated with OSI-774
- To determine the safety of OSI-774 in people 70 years of age or older [ Time Frame: 2 years ]
- To see how OSI-774 affects overall quality of life [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137800
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Pasi A Janne, MD, PhD||Dana-Farber Cancer Institute|