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Study Summary
No. 2005-0824:.......Lung......Edward Kim......Thoracic and Head and Neck Med
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Study Summary Title
Study Summary
Number:		2005-0824
Study Title:A Phase II, Open Label Study of Erlotinib (TarcevaŽ) in
Previously Treated Subjects with Advanced Non-Small Cell Lung Cancer
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Physician New Patient Referral
Name:Edward KimPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Thoracic and Head and Neck MedReferring 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:N/A
Phase of Study:Phase IIReturn
Visit:		Patients will return to the clinic every 4 weeks.
Treatment
Agents:		ErlotinibHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this clinical research study is to learn if Tarcevaâ (OSI-774,
erlotinib hydrochloride) can help to control NSCLC. The safety of this drug
will also be studied, as well as the drug's effect on different cells in the
body and the participants' overall response.
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Study Objectives / Outcomes
The primary objective is to determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen.

The secondary objectives of this study will be to:
ˇ Determine the overall response rate
ˇ Determine the overall survival
ˇ Determine the time to disease progression
ˇ Assess the safety/toxicity of the study treatment
• Assess biomarker modulation in the tumor tissue and serum samples from the treatment
• Assess plasma and intra-tumor concentrations of study treatment
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Study Status Information
Study Activation / Registration Date:11/29/2006
IRB Review and Approval Date:02/15/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:62 participants
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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:1) The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.

2) The patient has a diagnosis of either stage IIIB, stage IV, or advanced, incurable NSCLC, and failed at least one front-line metastatic NSCLC chemotherapy regimen. (Patients who have failed adjuvant or locally advanced therapy within 6 months are also eligible to participate in study).

3) The patient has uni-dimensionally measurable NSCLC.

4) Karnofsky performance status >/= 60 or ECOG performance status 0-2

5) The patient has biopsy accessible tumor.

6) The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm^3, platelet count >/= 100,000/mm^3, WBC >/= 3,000/ mm^3, and hemoglobin >/= 9 g/dL.

7) The patient has adequate hepatic function as defined by a total bilirubin level </= 1.5 X the upper limit of normal, and alkaline phosphatase, AST or ALT </= 2.5 X the upper limit of normal.

8) The patient has adequate renal function as defined by a serum creatinine level </= 1.5 mg/dL or a calculated creatinine clearance of >/= 60cc/minute.

9) The patient has PT < 1.5 x upper limit of normal

10) If patient has brain metastasis, they must have been stable (treated or asymptomatic) for at least 4 weeks after radiation, if treated with radiation, and not have used steroids for at least 1 week. Re-imaging performed after 2 weeks, upon completion of radiation therapy.

11) The patient is >/= 18 years of age.

12) The patient has signed informed consent.

13) The patient is eligible if disease free from a previously treated malignancy, other than a previous NSCLC, for greater than two years. Patients with a history of prior basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are exempt from exclusion.

14) Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of tudy participation. Childbearing potential will be defined as women who have had menses within the past 12 months,who have not had tubal ligation or bilateral oophorectomy.Should a woman become pregnant or suspect that she is pregnant while participating in this study,she should inform her treating physician immediately.The patient,if a man,agrees to use effective contraception or abstinence.

15) Subject must be considered legally capable of providing his or her own consent for participation in this study.
Exclusion Criteria:1) The patient has received prior investigational therapy, chemotherapy, surgery, or radiotherapy within 4 weeks of initiating study drug

2) The patient has undergone prior thoracic or abdominal surgery within 28 days of study entry, excluding prior diagnostic biopsy.

3) The patient has received radiation therapy to the measurable tumor within 6 months. Patients are allowed to have local irradiation for the management of tumor-related symptoms (bones, brain). However, if a patient has active new disease growing in the previously irradiated site, the patient will be eligible to participate in the study.

4) The patient has a significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure (New York Heart Association Functional Classification class II or worse), recent myocardial infarction within 3 months, unstable angina, active infection (i.e. currently treated with antibiotics, uncontrolled hypertension). Patients with controlled diabetes will be allowed. Patient must be able to undergo procedure for tissue acquisition.

5) The patient has uncontrolled seizure disorder, active neurologic disease, or neuropathy >/= grade 2. Patients with meningeal or CNS involvement by tumor are eligible for the study if the above exclusion criteria are not met.

6) The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.

7) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.

8) The patient is actively taking herbal remedies or over-the-counter biologics (e.g., shark cartilage, high dose antioxidants).

9) Patients will be allowed to have prior biologic (i.e. VEGF, EGFR, etc.) therapy. However, the patient will be excluded from a given study if he/she has received the same therapy as the clinical trial (i.e. If a patient has been previously treated with bevacizumab, they are allowed to enroll in any of the 4 studies. If a patient has been previously treated with erlotinib, they are excluded from the clinical trials with erlotinib). In addition, if a patient has been previously treated with gefitinib (Iressa), they are excluded from the clinical trials with erlotinib.

10) The patient has dysphagia. A patient who is unable to swallow intact capsules must be able to swallow capsules dissolved in water.

11) The patient has active gastrointestinal disease or a disorder that alters gastrointestinal motility or absorption (i.e., lack of integrity of the gastrointestinal tract such as a significant surgical resection of the stomach or small bowel).
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Links
Registration Number: NCT00410059
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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