Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Massachusetts General Hospital Brigham and Women's Hospital Genentech
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00137800

Purpose

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.

Condition	Intervention	Phase
Non-Small-Cell Lung Carcinoma	Drug: OSI-774 (Tarceva)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	80
Study Start Date:	February 2003
Estimated Study Completion Date:	January 2010
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Once daily without interruption as long as there is no disease progression or serious side effects experienced.

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.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137800

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Dana-Farber Cancer Institute

Massachusetts General Hospital

Brigham and Women's Hospital

Genentech

Investigators

Principal Investigator:

Pasi A Janne, MD, PhD

Dana-Farber Cancer Institute

More Information

Additional Information:

Dana-Farber Cancer Institute Lowe Thoracic Oncology Program This link exits the ClinicalTrials.gov site

Publications:

Shepherd 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.

Perez-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.

Responsible Party:	Dana-Farber Cancer Institute ( Pasi Janne, MD, PhD )
Study ID Numbers:	02-308
Study First Received:	August 29, 2005
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00137800 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

Non-Small Cell Lung Cancer
Elderly Cancer Patients
Tarceva

Erlotinib
OSI-774
Stage IIIB or IV Non-Small Cell Lung Cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Erlotinib
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009