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Spots Global Cancer Trial Database for Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery

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Trial Identification

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

Conditions

Sarcoma

Interventions

paclitaxel

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Nicolas Penel, MD

Affiliation: Centre Oscar Lambret

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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