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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00217607
First received: September 20, 2005
Last updated: December 13, 2009
Last verified: December 2006
  Purpose

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 Intervention Phase
Sarcoma
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate at 2 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate at 4 and 6 months [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Clinical criteria predicting response [ Designated as safety issue: No ]
  • Correlation of efficacy with the expression of genes involved in the angiogenesis regulation [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2005
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217607

Locations
France
Centre Paul Papin Recruiting
Angers, France, 49036
Contact: Philippe Maillart    33-2-4135-2700      
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Loic Chaigneau    33-81-668-240      
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Nguyen Binh Bui, MD    33-556-333-333      
Centre Regional Francois Baclesse Recruiting
Caen, France, 14076
Contact: Corinne Delcambre    33-2-3145-5000      
Centre Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Contact: Jacques-Olivier Bay, MD, PhD    33-73-278-080      
Centre de Lutte Contre le Cancer Georges-Francois Leclerc Recruiting
Dijon, France, 21079
Contact: Pierre Fargeot, MD    33-38-073-7506    pfargeot@dijon.frclcc.fr   
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Nicolas Penel, MD    33-3-20-295-920      
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Isabelle Ray-Coquard, MD    33-4-78-78-26-45      
Hopital Edouard Herriot - Lyon Recruiting
Lyon, France, 69437
Contact: Jean-Yves Blay, MD, PhD    33-47-211-7398    jy.blay@chu-lyon.fr   
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Florence Duffaud, MD    33-4-9138-5708    fduffaud@mail.ap-hm.fr   
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Didier Cupissol, MD, PhD    33-4-6761-3100    dcupissol@valdorel.fnclcc.fr   
Centre Regional Rene Gauducheau Recruiting
Nantes-Saint Herblain, France, 44805
Contact: Emmanuelle Bompas    33-2-40-479-959      
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Antoine Thyss, MD    33-04-9203-1538    antoine.thyss@cal.nice.fnclcc.fr   
Hopital Cochin Recruiting
Paris, France, 75674
Contact: Francois Goldwasser, MD, PhD    33-158-411-746    francois.goldwasser@cch.aphp.fr   
Institut Curie Hopital Recruiting
Paris, France, 75248
Contact: Sophie Piperno-Neumann, MD    33-44-32-4000      
Centre Eugene Marquis Recruiting
Rennes, France, 35042
Contact: Pierre Kerbrat, MD, PhD    33-299-253-280    kerbrat@rennes.fnclcc.fr   
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Cecile Guillemet, MD    33-02-32-02-2237    cecile.guillemet@rouen.fnclcc.fr   
Hopital Charles Nicolle Recruiting
Rouen, France, 76031
Contact: J.P. Vannier    33-2-3288-89-90      
Centre Rene Huguenin Recruiting
Saint Cloud, France, 92211
Contact: Michelle Tubiana-Hulin, MD    33-1-47-111-515      
Institut de Cancerologie de la Loire Recruiting
Saint Priest En Jarez, France, 42270
Contact: Olivier Collard, MD    33-477-91-7036      
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Christine Chevreau-Dalbianco, MD    33-56-142-4114    chevreau.christine@claudiusregaud.fr   
Centre Hospitalier Universitaire Bretonneau de Tours Recruiting
Tours, France, 37044
Contact: Lotfi Benboubker    33-02-4747-3712      
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Axel Le Cesne, MD    33-1-42-114-316    lecesne@igr.fr   
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Nicolas Penel, MD Centre Oscar Lambret
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00217607     History of Changes
Other Study ID Numbers: CDR0000441642, FRE-FNCLCC-SARCOME-06/0409, EU-20517
Study First Received: September 20, 2005
Last Updated: December 13, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult angiosarcoma
recurrent adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Hemangiosarcoma
Lymphangiosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Lymphatic Vessel Tumors
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014