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Study Summary
No. 2003-0593:.......Lung......Roy S. Herbst......Thoracic and Head and Neck Medical Oncology
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Study Summary Title
Study Summary
Number:		2003-0593
Study Title:A Multicenter Phase 2 Trial of OSI-774 (Erlotinib, Tarceva) in Patients with Advanced Bronchioloalveolar Cell Lung Cancer
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Physician New Patient Referral
Name:Roy S. HerbstPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Thoracic and Head and Neck Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6363
Contact us about clinical trials
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General Information
Disease Group:LungSupported By:VANDERBILT UNIV MED CTR
Phase of Study:Phase IIReturn
Visit:		WEEKLY VISITS UP UNTIL WEEK 5; THEN EVERY 4 WEEKS.
Treatment
Agents:		Biopsy
OSI-774		Home Care:NONE
Treatment Loc:outpatient
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:01/22/2004
IRB Review and Approval Date:08/20/2003
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:25
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria: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.

Life expectancy equal to or greater than 8 weeks.

Adequate hematologic, renal and/or hepatic function: WBC equal to or greater than 3,000/ul, hemoglobin equal to or greater than 9.0 g/dl, platelet count equal to or greater than 100,000/ul, total bilirubin equal to or less than 1.0 mg/dl, AST equal to or less than 2.0 x UNL, creatinine equal to or less than 1.5 mg/dl or Clcr equal to or greater than 55 ml/min.

Signed informed consent.

Effective contraception.

Pathologic evidence of either bronchioloalveolar cell carcinoma or a variant thereof after review by the reference MSKCC pathologist, Vanderbilt pathologist, MD Anderson pathologist, Northwestern pathologist or Dana-Farber pathologist.

ECOG less than or equal to 1 OR Karnofsky performance status greater than or equal to 80 percent.
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).
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Links
Registration Number:
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Results

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