Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2

Tracking Information
First Submitted Date ICMJE	March 7, 2000
First Posted Date ICMJE	September 30, 2003
Last Update Posted Date	January 16, 2013
Study Start Date ICMJE	February 2000
Actual Primary Completion Date	August 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 15, 2013)	Response rate (complete response [CR] and partial response [PR]) [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00004883 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: January 15, 2013)	Overall survival (OS) [ Time Frame: From registration until death or last known follow-up, assessed up to 5 years ]Kaplan-Meier curves will be used to describe OS.; Failure-free survival (FFS) [ Time Frame: Time between registration and disease progression, death, or last known follow-up, assessed up to 5 years ]Kaplan-Meier curves will be used to describe FFS.; Duration of response [ Time Frame: Time between the initial documentation of response and subsequent failure (death, disease progression), assessed up to 5 years ]Kaplan-Meier curves will be used to describe duration of response.; Toxicity as assessed by NCI's Common Toxicity Criteria [ Time Frame: Up to 5 years ]The frequency of occurrence of various toxicities will be tabulated by the most severe occurrence experienced by each individual patient.; Relationship between HER2 expression in tumor tissue and serum [ Time Frame: Up to 5 years ]A 95% confidence interval for this proportion will be estimated using the binomial distribution. The level of circulating HER2 receptor will be descriptively summarized with means, medians, quartiles, etc.
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
Official Title ICMJE	A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer
Brief Summary	Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
Detailed Description	PRIMARY OBJECTIVES: I. Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer. SECONDARY OBJECTIVES: I. Determine the duration of response in patients treated with this regimen. II. Determine the toxicity of this treatment regimen in this patient population. III. Assess levels of circulating HER2 and correlate with HER2 expression in this patient population. V. Correlate circulating HER2 levels with non-small cell lung cancer tissue HER2 expression. OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks until disease progression or death. PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study within 17.5 months.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
Intervention ICMJE	Biological: trastuzumab Given IV Other Names: anti-c-erB-2 Herceptin MOAB HER2; Other: laboratory biomarker analysis Correlative studies
Study Arms	Experimental: Treatment (trastuzumab); Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity.; Interventions: Biological: trastuzumab; Other: laboratory biomarker analysis
Publications *	Not Provided
* 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	Completed
Actual Enrollment ICMJE; (submitted: January 15, 2013)	84
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Actual Primary Completion Date	August 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Histologically confirmed stage IIIB or IV non-small cell lung cancer Supraclavicular node involvement allowed Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative); No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy; Recurrent disease allowed; HER2 overexpression (2-3+); At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques At least 10 mm by spiral CT scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging Cystic lesions; No CNS metastases; Performance status - ECOG 0-2; Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Bilirubin no greater than 1.5 times upper limit of normal (ULN); Creatinine no greater than 1.5 times ULN; LVEF at least 45% (by echocardiogram or MUGA); Not pregnant or nursing; Fertile patients must use effective contraception; HIV negative; No concurrent immunologic disease (e.g., autoimmune disease); No history of allergy to murine products; No prior murine antibodies; No prior anthracyclines; No more than 1 prior chemotherapy regimen for lung cancer; At least 4 weeks since prior chemotherapy; No concurrent chemotherapy; No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic; No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes); At least 6 months since prior radiotherapy; No concurrent palliative radiotherapy; At least 4 weeks since prior major surgery
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00004883
Other Study ID Numbers ICMJE	NCI-2012-02318; CLB-39810; U10CA031946 ( U.S. NIH Grant/Contract ); CDR0000067555 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Cancer Institute (NCI)
Study Sponsor ICMJE	National Cancer Institute (NCI)
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Gerald Clamon Cancer and Leukemia Group B
PRS Account	National Cancer Institute (NCI)
Verification Date	January 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP