Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Objective Response Rate [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Time to progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Clinical criteria predicting response [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Correlation of efficacy with the expression of genes involved in the angiogenesis regulation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||January 2012|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Paclitaxel 80 mg/m² Day 1, Day 8 and Day 15. No treatment on Day 22.
1 cycle = 28 days.
Treatment duration: 6 cycles (=6 months)
- Determine the 2-month objective response rate in patients with locally advanced or metastatic, unresectable soft tissue angiosarcoma or lymphangiosarcoma treated with paclitaxel.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217607
|Centre Paul Papin|
|Angers, France, 49036|
|Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz|
|Besancon, France, 25030|
|Bordeaux, France, 33076|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Leon Berard|
|Lyon, France, 69373|
|Hopital Edouard Herriot - Lyon|
|Lyon, France, 69437|
|CHU de la Timone|
|Marseille, France, 13385|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Institut Curie Hopital|
|Paris, France, 75248|
|Paris, France, 75674|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Hopital Charles Nicolle|
|Rouen, France, 76031|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Institut de Cancerologie de la Loire|
|Saint Priest en Jarez, France, 42270|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Nicolas Penel, MD||Centre Oscar Lambret|