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
  Purpose

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


Condition Intervention Phase
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Biological: trastuzumab
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (complete response [CR] and partial response [PR]) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 84
Study Start Date: February 2000
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: trastuzumab
Given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004883

Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
Investigators
Principal Investigator: Gerald Clamon Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004883     History of Changes
Other Study ID Numbers: NCI-2012-02318, CLB-39810, U10CA031946, CDR0000067555
Study First Received: March 7, 2000
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014