Full Text View
Tabular View
No Study Results Posted
Related Studies
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Overexpresses HER2
This study has been completed.

First Received on March 7, 2000.   Last Updated on February 6, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004883
  Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

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.


Condition Intervention Phase
Lung Cancer
Biological: trastuzumab
Phase II

Study Type: Interventional
Study Design: 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):

Study Start Date: February 2000
Detailed Description:

OBJECTIVES:

  • Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer.
  • Determine the duration of response in patients treated with this regimen.
  • Determine the toxicity of this treatment regimen in this patient population.
  • Assess levels of circulating HER2 and correlate with HER2 expression in this patient population.

OUTLINE: Patients are stratified according to prior treatment (yes vs no).

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

DISEASE CHARACTERISTICS:

  • 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 OR
    • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • LVEF at least 45% (by echocardiogram or MUGA)

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior murine antibodies

Chemotherapy:

  • See Disease Characteristics
  • No prior anthracyclines
  • No more than 1 prior chemotherapy regimen for lung cancer
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • 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)

Radiotherapy:

  • See Disease Characteristics
  • At least 6 months since prior radiotherapy
  • No concurrent palliative radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004883

  Show 48 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Gerald H. Clamon, MD Holden Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00004883     History of Changes
Other Study ID Numbers: CDR0000067555, CLB-39810
Study First Received: March 7, 2000
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

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

ClinicalTrials.gov processed this record on February 12, 2012