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

NCT ID: NCT00004883

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29

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.

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

trastuzumab

Intervention Type: BIOLOGICAL

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

trastuzumab

Given IV

Intervention Type: BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

anti-c-erB-2; Herceptin; MOAB HER2

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerald Clamon

Role: PRINCIPAL_INVESTIGATOR

Cancer and Leukemia Group B

Locations

Cancer and Leukemia Group B

Chicago, Illinois, United States

Countries

United States

Other Identifiers

CLB-39810

Identifier Type: -

Identifier Source: secondary_id

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000067555

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02318

Identifier Type: -

Identifier Source: org_study_id