Ph II OSI-774 (Erlotinib,Tarceva) In Advanced Bronchioloalveolar Cell Lung Cancer

Study Overview
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Brief Summary
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The primary objective of this study is to determine the major objective response rate of OSI-774 in participants with unresectable or metastatic bronchioloalveolar cell variant of non-small cell lung cancer. This study is a Phase II study. The first study of OSI-774 was done to evaluate what dose should be given to patients with cancer has been completed. The purpose of this research study is to see whether this experimental treatment, called OSI-774, can cause a type of non-small cell lung cancer to stop growing or shrink. This study is sponsored by a company called Genentech, and is being done at Memorial Hospital, as well as other cancer centers around the country interested in developing new drugs for the treatment of this type of cancer.

Official Title
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Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) In Patients With Advanced Bronchioloalveolar Cell Lung Cancer

Conditions
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Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: OSI-774: erlotinib, TarcevaTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Either bronchioloalveolar cell carcinoma or a variant thereof after review Clinical stage IIIB (malignant pleural or pericardial effusion) or IV or recurrent/medically inoperable disease Measurable or evaluable indicator lesions No prior or one chemotherapy regimen for NSCLC Three weeks since last chemotherapy, and three weeks since prior radiation therapy to a major bone-marrow containing area Karnofsky performance status > or = to 80% OR ECOG performance status ≤ or = to 1 Life expectancy > or = to 8 weeks Adequate hematologic, renal and/or hepatic function: WBC > or = to 3,000/ul, hemoglobin > or = to 9.0 g/dl, platelet count > or = to 100,000/ul, total bilirubin < or = to 1.0 mg/dl, AST < than or = to 2.5 X UNL, creatinine < or = to 1.5 mg/dl or Clcr > or = to 55ml/min. Effective contraception Exclusion Criteria: Prior exposure to OSI-774 or other treatments targeting the HER family axis (e.g.-trastuzumab, ZD1839, C225, etc.) Two or more prior chemotherapy regimens Concurrent active cancer Uncontrolled central nervous system metastases (i.e. any known CNS lesion which is radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids) Pregnant or lactating women Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin Prior systemic cytotoxic chemotherapy for other malignant disease Significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure, recent MI, unstable angina, active infection, uncontrolled hypertension).
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - OSI-774<br> | Drug: OSI-774: erlotinib, TarcevaTM<br>* 150 mg, 100 mg and 25 mg tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Objective Response of OSI-774 | (complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. A complete response is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions. Stable disease is defined as fitting the criteria neither for progressive disease nor a PR. | 53 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non small cell lung cancer