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Brief Title: Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery
Official Title: Multicentric Phase II Study Evaluating the Efficacy and Toxicity of Weekly Paclitaxel in Locally Advanced or Metastatic Soft Tissue Angiosarcomas That Cannot be Treated by Surgery
Study ID: NCT00217607
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery.
Detailed Description: OBJECTIVES: Primary * Determine the 2-month objective response rate in patients with locally advanced or metastatic, unresectable soft tissue angiosarcoma or lymphangiosarcoma treated with paclitaxel. Secondary * Determine the 4- and 6-month response rate in patients treated with this drug. * Determine tolerability of this drug in these patients. * Determine the time to disease progression and overall survival of patients treated with this drug. * Determine the clinical criteria predicting response in patients treated with this drug. * Correlate the efficacy of this drug with the expression of genes involved in angiogenesis regulation in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Paul Papin, Angers, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz, Besancon, , France
Institut Bergonie, Bordeaux, , France
Centre Regional Francois Baclesse, Caen, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc, Dijon, , France
Centre Oscar Lambret, Lille, , France
Centre Leon Berard, Lyon, , France
Hopital Edouard Herriot - Lyon, Lyon, , France
CHU de la Timone, Marseille, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, , France
Centre Regional Rene Gauducheau, Nantes-Saint Herblain, , France
Centre Antoine Lacassagne, Nice, , France
Institut Curie Hopital, Paris, , France
Hopital Cochin, Paris, , France
Centre Eugene Marquis, Rennes, , France
Hopital Charles Nicolle, Rouen, , France
Centre Henri Becquerel, Rouen, , France
Centre Rene Huguenin, Saint Cloud, , France
Institut de Cancerologie de la Loire, Saint Priest en Jarez, , France
Institut Claudius Regaud, Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours, Tours, , France
Institut Gustave Roussy, Villejuif, , France
Name: Nicolas Penel, MD
Affiliation: Centre Oscar Lambret
Role: STUDY_CHAIR