Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery
NCT ID: NCT00217607
Last Updated: 2016-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2005-02-28
2012-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Paclitaxel
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)
paclitaxel
Interventions
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paclitaxel
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed soft tissue angiosarcoma or lymphangiosarcoma
* Locally advanced or metastatic disease
* Unresectable disease
* Angiosarcomas in previously irradiated areas allowed provided disease is clearly progressive
* Measurable disease
* No Kaposi's sarcoma
PATIENT CHARACTERISTICS:
Age
* 18 to 70
Performance status
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
Hepatic
* Bilirubin \< 3 times upper limit of normal (ULN)
* SGOT and SGPT \< 2.5 times ULN
* No severe liver failure
Renal
* Creatinine clearance \> 60 mL/min
* No severe kidney failure
Cardiovascular
* LVEF ≥ 50%
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No weight loss ≥ 20% of body weight prior to illness
* Patient must be amenable to receiving care during the day
* No HIV positivity
* No clinical neuropathy
* No known allergy to study drug or to any of its components (e.g., Cremophor EL)
* No other progressive malignant tumor
* No chronic illness (somatic or psychiatric) that would preclude study compliance and follow-up
* No psychological, geographical, or social reason that would preclude study follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No more than 2 prior courses of chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
Surgery
* Not specified
Other
* No other concurrent anticancer therapy
* No concurrent participation in another therapeutic investigational study
18 Years
70 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Nicolas Penel, MD
Role: STUDY_CHAIR
Centre Oscar Lambret
Locations
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Centre Paul Papin
Angers, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , 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
Countries
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References
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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.
Other Identifiers
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FRE-FNCLCC-SARCOME-06/0409
Identifier Type: -
Identifier Source: secondary_id
EU-20517
Identifier Type: -
Identifier Source: secondary_id
CDR0000441642
Identifier Type: -
Identifier Source: org_study_id
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