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

NCT00004883 | Completed Phase 2

• 4 other identifiers: NCI-2012-02318CLB-39810U10CA031946CDR0000067555
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Response rate (complete response [CR] and partial response [PR])

  Up to 5 years

Secondary Outcomes (5)

• Overall survival (OS)

  From registration until death or last known follow-up, assessed up to 5 years

• Failure-free survival (FFS)

  Time between registration and disease progression, death, or last known follow-up, assessed up to 5 years

• Duration of response

  Time between the initial documentation of response and subsequent failure (death, disease progression), assessed up to 5 years

• Toxicity as assessed by NCI's Common Toxicity Criteria

  Up to 5 years

• Relationship between HER2 expression in tumor tissue and serum

  Up to 5 years

Study Arms (1)

Treatment (trastuzumab)

EXPERIMENTAL

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; Other: laboratory biomarker analysis

Interventions

trastuzumab BIOLOGICAL

Given IV

Also known as: anti-c-erB-2, Herceptin, MOAB HER2

Treatment (trastuzumab)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (trastuzumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gerald Clamon

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: September 30, 2003
• Study Start: February 1, 2000
• Primary Completion: August 1, 2005
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)