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Pancreas Cancer News and Archives | |
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38th Annual Meeting of the
American Society of Clinical Oncology Features More Than 200
Abstracts On Taxotere(R)
The results of Phase III clinical studies involving the use of the chemotherapy agent Taxotere® (docetaxel) for Injection Concentrate to treat patients with early stage breast cancer, ovarian cancer and non-small cell lung cancer (NSCLC) will be presented this week at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Fla. The ASCO meeting begins on Saturday, May 18th and runs through Tuesday, May 21st. The Society published a total of 243 abstracts for studies involving Taxotere®, and selected 12 of these for discussion during the meeting's oral presentation sessions. Other Taxotere® data to be presented include Phase I and II trials in NSCLC, breast, prostate, ovarian, head and neck and pancreatic cancers as well as abstracts on Taxotere® in combination with a variety of novel anticancer agents. Breast Cancer Among the findings to be announced at the conference are the interim results of a Phase III multinational study comparing a combination of Taxotere®, Adriamycin® (doxorubicin) and Cytoxan® (cyclophosphamide), known as TAC, to a combination of 5-Fluorouracil, Adriamycin and Cytoxan, known as FAC, in the adjuvant (after surgery) treatment of node-positive, early- stage breast cancer patients. The FAC combination is considered one of the standard treatment regimens in the United States and globally. The primary objective of this trial is to compare the rates of disease-free survival (no cancer relapse) and overall survival between patients treated with TAC and FAC. The principal investigator, Jean-Marc Nabholtz, M.D., professor of medicine at the University of California at Los Angeles (UCLA) and director of the Cancer Therapy Development Program at the Jonsson Comprehensive Cancer Center at UCLA, will report the results. Findings from another study of patients with inflammatory or locally advanced breast cancer will be presented by Judith Hurley, M.D., assistant professor of medicine at the University of Miami in Miami, Fla. The Phase II study tested a combination of Taxotere®, cisplatin and Herceptin® (trastuzumab) as preoperative or neoadjuvant therapy. The primary objective of this trial is to determine the efficacy of this combination. Ovarian Cancer Paul A. Vasey, M.D., medical oncologist at the Cancer Research Campaign Clinical Trials Unit at Beatson Oncology Centre at the Western Infirmary in Glasgow, Scotland, and a principal investigator for the Scottish Gynaecologic Cancer Trials Group, will present updated results from a Phase III study that compared a combination of paclitaxel and carboplatin to a combination of Taxotere® and carboplatin as first-line chemotherapy for early to advanced stage epithelial ovarian cancer. The information that will be discussed includes comparisons of relapse rates between the two groups, as well as neurotoxicity (nerve damage) and quality of life. Non-Small Cell Lung Cancer (NSCLC) R.J. Gralla, M.D., professor of medicine, at Columbia University College of Physicians & Surgeons, New York, will present a prospective analysis of quality of life of patients involved in a randomized, multinational Phase III study comparing two regimens -- Taxotere® plus cisplatin and Taxotere® plus carboplatin -- to vinorelbine plus cisplatin as first-line therapy for patients with advanced NSCLC. Dr. Gralla will report on the largest prospective evaluation of quality of life in patients with NSCLC treated with chemotherapy. The analysis measures quality of life using validated instruments such as the Lung Cancer Symptom Scale (LCSS) and Euroqol (EQ5D). Prostate Cancer A Phase II trial of calcitriol (active form of Vitamin D) and Taxotere® in patients with androgen-independent prostate cancer (AIPC) will be presented by Tomasz M. Beer, M.D., assistant professor of medicine at Oregon Health & Science University in Portland, Ore. The objective of this study is to determine whether the addition of high-dose calcitriol may enhance the therapeutic response of Taxotere® in AIPC. The primary endpoint of this study was prostate-specific antigen (PSA) response. Other outcomes monitored include tumor response, survival, and time to disease progression. Novel Agents New data highlighting the potential role of Taxotere® in combination with novel agents will be presented at this year's meeting. Novel agents being studied in combination with Taxotere® include Thalomid® (thalidomide) and Celebrex® (celecoxib capsules), and the following investigational drugs: Tarceva(TM) (OSI-774), Erbitux(TM) (cetuximab), LY900003 (formerly known as ISIS-3521), SGN15, MLN-341 (formerly known as PS-341) and Flavopiridol. About Taxotere® Taxotere®, a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Taxotere® promotes their assembly and blocks their disassembly, thereby preventing cancer cells from dividing and resulting in cancer cell death. Taxotere® is currently approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. The most common severe side effects associated with Taxotere® include low blood cell count, fatigue, fluid retention and mouth sores. The most common non- severe side effects included hair loss, neurosensory, cutaneous, nail changes, nausea and diarrhea. These side effects are generally reversible and manageable. A premedication regimen with corticosteroids is recommended in order to prevent or reduce hypersensitivity and fluid retention. Taxotere® is not appropriate therapy for patients with significant liver impairment or a low white blood cell count. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit http://www.taxotere.com or http://www.aventisoncology.com. About Aventis Aventis Pharmaceuticals conducts the U.S. prescription drug business of Aventis. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes, and the central nervous system. Aventis is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes and respiratory disorders as well as on human vaccines. In 2001, Aventis generated sales of _ 17.7 billion ($15.9 billion), invested approx. _ 3 billion ($2.7 billion) in research and development and employed approximately 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: http://www.aventis.com. Full prescribing information is available by visiting the Aventis Pharmaceuticals U.S. Web site at http://www.aventispharma-us.com. Also available at this U.S. Web site are copies of this release or any recent release, or call 800/207-8049. Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission. Press Release |
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