Clinical trial NCT00004883: Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
Official title: A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-09-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response rate (complete response [CR] and partial response [PR])
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: From registration until death or last known follow-up, assessed up to 5 years
measure: Failure-free survival (FFS)
timeFrame: Time between registration and disease progression, death, or last known follow-up, assessed up to 5 years
measure: Duration of response
timeFrame: Time between the initial documentation of response and subsequent failure (death, disease progression), assessed up to 5 years
measure: Toxicity as assessed by NCI's Common Toxicity Criteria
timeFrame: Up to 5 years
measure: Relationship between HER2 expression in tumor tissue and serum
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cancer and Leukemia Group B
state: Illinois
Study officials:
affiliation: Cancer and Leukemia Group B
name: Gerald Clamon
role: PRINCIPAL_INVESTIGATOR
References: