Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

UNICANCER

Conditions:

Sarcoma

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

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...

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 paclitaxe...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2012

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00217607

    Start Date

    February 1 2005

    End Date

    January 1 2012

    Last Update

    August 30 2016

    Active Locations (23)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (23 locations)

    1

    Centre Paul Papin

    Angers, France, 49036

    2

    Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, France, 25030

    3

    Institut Bergonie

    Bordeaux, France, 33076

    4

    Centre Regional Francois Baclesse

    Caen, France, 14076