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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004883
First received: March 7, 2000
Last updated: January 15, 2013
Last verified: January 2013

March 7, 2000
January 15, 2013
February 2000
August 2005   (final data collection date for primary outcome measure)
Response rate (complete response [CR] and partial response [PR]) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00004883 on ClinicalTrials.gov Archive Site
  • Overall survival (OS) [ Time Frame: From registration until death or last known follow-up, assessed up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer

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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Biological: trastuzumab
    Given IV
    Other Names:
    • anti-c-erB-2
    • Herceptin
    • MOAB HER2
  • Other: laboratory biomarker analysis
    Correlative studies
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
Not Provided
August 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004883
NCI-2012-02318, CLB-39810, U10CA031946, CDR0000067555
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Gerald Clamon Cancer and Leukemia Group B
National Cancer Institute (NCI)
January 2013

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