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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene -- Ignore unavailable to you. Want to Upgrade?

To: Vector1 who wrote (181)	9/24/2002 10:38:32 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 447

So far (and to my knowledge) this is first trial which will combine VEGFr-EGFr inhibitors. It is initiated, according to protocol, somewhere in spring '02. Miljenko VICC THO 0206 A Phase I/II, Multidose, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the Combination of Recombinant Humanized Monoclonal Antibody rhumba VEGF (Avastin) and the EGFR Tyrosine kinase Inhibitor OSI-774 (Tarceva) for Locally Advanced or Metastatic Non-Squamous Cell Non-Small Cell Lung Cancer in patients who have been Previously Treated. Investigator: Alan B. Sandler, MD -------------------------------------------------------------------------------- Study Description -------------------------------------------------------------------------------- This study is for patients who have advanced or metastatic non-small cell lung cancer (NSCLC). The purpose of this study is to see how effective the combination of Tarceva and Avastin is on this type of cancer. Another purpose is to see what is the highest, most effective dose of the combination that can be given to patients. Tarceva is an investigational (not FDA approved) selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase (a protein involved in tumor growth). EGFR is a protein found on the surface of may tumor cells that may control tumor growth. Avastin is an investigational (not FDA approved) drug which prevents the development of new blood vessels in tumors and may be effective in suppressing the growth of tumors. Another purpose of this study is to determine the effects (good and bad) on each patient caused by the two investigational drugs given in combination as treatment for this disease. There will be about 50 patients participating in this study from Vanderbilt University and the University of Texas M.D. Anderson. -------------------------------------------------------------------------------- Treatment Agents -------------------------------------------------------------------------------- The treatment agents used in this study are Tarceva and Avastin. Tarceva is an investigational (not FDA approved) selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase (a protein involved in tumor growth). EGFR is a protein found on the surface of may tumor cells that may control tumor growth. Avastin is an investigational (not FDA approved) drug which prevents the development of new blood vessels in tumors and may be effective in suppressing the growth of tumors. -------------------------------------------------------------------------------- Inclusion Criteria -------------------------------------------------------------------------------- Patients must have histologically proven Stage IIIB/IV or recurrent non-squamous non-small cell lung cancer (NSCLC). Patients must have Karnofsky performance status >=70%. Patients must have adequate bone marrow function: WBC >=3,000 cells/mm3 ANC>=1,500 cells/mm3 platelet count >=100,000 cells/mm3 Hgb >=9.0 g/dL Patients must have adequate liver function: total bilirubin level <=2.0 mg/dL albumin >= 2.5 g/dL Patient transaminases (SGOT and/or SGPT) and alkaline phosphatase may be up to 2.5 x upper limit of normal and patients still be eligible. Patients must have adequate renal function: a serum creatinine <2 mg/dl Patients must sign written informed consent. Patients must have received at least one prior chemotherapeutic regimen for recurrent or metastatic disease. Patients who have not received prior chemotherapeutic regimens for advanced disease are not eligible. Patients who have received prior biologic therapy targeting EGFR and/or VEFG are not eligible. Patients who have received radiation therapy within the past three weeks are not eligible. Patients who have signs or symptoms of acute infection requiring systemic therapy are not eligible. Patients who exhibit confusion, disorientation, or who have a history of major psychiatric illness that may impair understanding of informed consent are not eligible. Patients who have a life expectancy of <6 months are not eligible. Patients who require total parenteral nutrition with lipids are not eligible. Patients who have history of uncontrolled heart disease are not eligible. Because of the possible teratogenic effect, pregnant women and women who are currently breast-feeding may not participate in this study. All women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to enrolling in this study. Patients with serious infection of other intercurrent illness requiring immediate therapy are not eligible. Patients with evidence of CNS metastatic disease by MRI/CT or who have history of CNS disease are not eligible. Pediatric patients in whom open growth plates would be expected are not eligible. Patients with proteinuria are not eligible.