Safety/Efficacy Study of Immunoconjugate With Docetaxel in Non-small Cell Lung Carcinoma
Carcinoma, Non-Small-Cell Lung

About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
INCLUSION CRITERIA: Patients with pathologically confirmed NSCLC which is metastatic or recurrent (non-resectable), who have failed at least one but no more than two prior therapies for advanced stage disease or have a recurrence within 6 months of completing adjuvant chemotherapy. Lewis-y antigen expression documented by immunohistochemistry for all patients. Patients must have: Bidimensionally or unidimensionally measurable disease on the basis of physical exam or imaging studies, or Evaluable disease: bone metastases defined on bone scan or malignant pleural effusion Performance status ≤ 2 (ECOG scale) with a life expectancy of at least 3 months Patients must be at least four weeks from prior treatment (chemotherapy, hormonal therapy, or definitive radiotherapy) EXCLUSION CRITERIA: Prior therapy with TAXOTERE (docetaxel) Cumulative anthracycline exposure > 300 mg/m2. More than one primary malignancy with the exception of: Non-melanoma skin cancer In situ carcinoma of the cervix Localized prostate cancer Completely resected stage I or II disease with no evidence of recurrent cancer from which the patient has remained disease free for more than 3 years. Uncontrolled significant non-malignant disease (e.g. congestive heart failure, bleeding, renal failure, hepatic failure). Uncontrolled, symptomatic brain metastasis. Peripheral neuropathy > grade 2. Concomitant therapy with other anti-neoplastic agents or experimental agents except for small volume radiation to a solitary bony metastasis. Active viral, bacterial or systemic fungal infections including known HIV or Hepatitis B or C. Women who are pregnant or breastfeeding Any serious underlying medical condition, which would impair the ability of the patient to receive the planned treatment including prior allergic reactions to recombinant human or murine proteins. Dementia or altered mental status that would prohibit the understanding and rendering of informed consent. Patients with uncontrolled peptic ulcer disease will be excluded.
Sites / Locations
- UCLA Medical Center
- Bendheim Cancer Center
- Florida Cancer Specialists
- Hematology Oncology Associates of the Treasure Coast
- University of Chicago
- Providence Health System
- Kaiser Permanente
- Virginia Mason Research Center
- Madigan Army Medical Center