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Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients
This study is ongoing, but not recruiting participants.
Study NCT00137800   Information provided by Dana-Farber Cancer Institute
First Received: August 29, 2005   Last Updated: October 30, 2009   History of Changes

August 29, 2005
October 30, 2009
February 2003
May 2005   (final data collection date for primary outcome measure)
  • To determine how well non-small cell lung cancer cells in the body respond to OSI-774 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the survival rate of patients treated with OSI-774 [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • * To determine how well non-small lung cancer cells in the body respond to OSI-774
  • * To determine the survival rate of patients treated with OSI-774
Complete list of historical versions of study NCT00137800 on ClinicalTrials.gov Archive Site
  • To determine the safety of OSI-774 in people 70 years of age or older [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To see how OSI-774 affects overall quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • * To determine the safety of OSI-774 in people 70 years of age or older
  • * To see how OSI-774 affects overall quality of life
 
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)

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.

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.

Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Non-Small-Cell Lung Carcinoma
Drug: OSI-774 (Tarceva)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
80
January 2010
May 2005   (final data collection date for primary outcome measure)

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
Both
70 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00137800
Pasi Janne, MD, PhD, Dana-Farber Cancer Institute
02-308
Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Genentech
Principal Investigator: Pasi A Janne, MD, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP