Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00217607
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 30, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: paclitaxel Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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)

Drug: paclitaxel

Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 4 months ]
  2. Response rate [ Time Frame: 6 months ]
  3. Tolerability [ Time Frame: 6 months ]
  4. Time to progression [ Time Frame: 5 years ]
  5. Overall survival [ Time Frame: 5 years ]
  6. Clinical criteria predicting response [ Time Frame: 2 months ]
  7. Correlation of efficacy with the expression of genes involved in the angiogenesis regulation [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 70

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3


  • Bilirubin < 3 times upper limit of normal (ULN)
  • SGOT and SGPT < 2.5 times ULN
  • No severe liver failure


  • Creatinine clearance > 60 mL/min
  • No severe kidney failure


  • LVEF ≥ 50%


  • 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


Biologic therapy

  • Not specified


  • No more than 2 prior courses of chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics


  • Not specified


  • No other concurrent anticancer therapy
  • No concurrent participation in another therapeutic investigational study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00217607

Centre Paul Papin
Angers, France, 49036
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
Institut Bergonie
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
Hopital Cochin
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
Sponsors and Collaborators
Study Chair: Nicolas Penel, MD Centre Oscar Lambret

Publications of Results:
Responsible Party: UNICANCER Identifier: NCT00217607     History of Changes
Other Study ID Numbers: CDR0000441642
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared at an individual level.

Keywords provided by UNICANCER:
adult angiosarcoma
recurrent adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action