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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-FNCLCC-SARCOME-06/0409 | |||
| EU-20517 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | 4 months | |
| Response rate | 6 months | |
| Tolerability |
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DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue angiosarcoma or lymphangiosarcoma
Angiosarcomas in previously irradiated areas allowed provided disease is clearly progressive
Measurable disease
No Kaposi's sarcoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Penel, MD | Centre Oscar Lambret | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Papin | Angers | 49036 | France | |||
| Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18809609 | Result | Penel N, Bui BN, Bay JO, Cupissol D, Ray-Coquard I, Piperno-Neumann S, Kerbrat P, Fournier C, Taieb S, Jimenez M, Isambert N, Peyrade F, Chevreau C, Bompas E, Brain EG, Blay JY. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOTAX Study. J Clin Oncol. 2008 Nov 10;26(32):5269-74. doi: 10.1200/JCO.2008.17.3146. Epub 2008 Sep 22. |
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Individual participant data will not be shared at an individual level.
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| 6 months |
| Time to progression | 5 years |
| Overall survival | 5 years |
| Clinical criteria predicting response | 2 months |
| Correlation of efficacy with the expression of genes involved in the angiogenesis regulation | 6 months |
| Besançon |
| 25030 |
| France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | Dijon | 21079 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Hopital Edouard Herriot - Lyon | Lyon | 69437 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| Centre Regional Rene Gauducheau | Nantes-Saint Herblain | 44805 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Institut Curie Hopital | Paris | 75248 | France |
| Hopital Cochin | Paris | 75674 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Hopital Charles Nicolle | Rouen | 76031 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Centre Rene Huguenin | Saint-Cloud | 92211 | France |
| Institut de Cancerologie de la Loire | Saint-Priest-en-Jarez | 42270 | France |
| Institut Claudius Regaud | Toulouse | 31052 | France |
| Centre Hospitalier Universitaire Bretonneau de Tours | Tours | 37044 | France |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D006394 | Hemangiosarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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