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

Study Overview
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Brief Summary
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This randomized phase II clinical trial evaluates the combination of a monoclonal antibody-based drug (SGN-15) with a chemotherapeutic agent compared to chemotherapy given alone in patients with non-small cell lung cancer that has failed at least one prior systemic therapy. The objective of the study is to determine the safety and clinical benefit, as measured by tumor response and quality of life, to the combination regimen. Monoclonal antibody therapy has been used in other types of cancer to target therapy to the tumor, thereby allowing for the chemotherapeutic agent to have a lesser effect on normal, healthy tissue.

Official Title
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A Phase II Study Using SGN-15 (cBR96-Doxorubicin Immunoconjugate) in Combination With Docetaxel for the Treatment of Advanced Stage or Recurrent Non-Small Cell Lung Carcinoma

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: SGN-15
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SGN-15|nan|
|Drug: Docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma, Non-Small-Cell Lung