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

Completed · Phase 2

Conditions studied: Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT00004883

Run by

National Cancer Institute (NCI)

People needed

84

Starts

2000-02-01

Last updated by the study team

2013-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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