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

August 29, 2016 updated by: UNICANCER

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49036
        • Centre Paul Papin
      • Besancon, France, 25030
        • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69437
        • Hopital Edouard Herriot - Lyon
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Marseille, France, 13385
        • CHU de la Timone
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Nantes-Saint Herblain, France, 44805
        • Centre Regional Rene Gauducheau
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75674
        • Hôpital Cochin
      • Paris, France, 75248
        • Institut Curie Hopital
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Rouen, France, 76031
        • Hopital Charles Nicolle
      • Saint Cloud, France, 92211
        • Centre René Huguenin
      • Saint Priest en Jarez, France, 42270
        • Institut de Cancerologie de La Loire
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Tours, France, 37044
        • Centre Hospitalier Universitaire Bretonneau de Tours
      • Villejuif, France, F-94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 years
5 years
Time to progression
Time Frame: 5 years
5 years
Response rate
Time Frame: 4 months
4 months
Response rate
Time Frame: 6 months
6 months
Tolerability
Time Frame: 6 months
6 months
Clinical criteria predicting response
Time Frame: 2 months
2 months
Correlation of efficacy with the expression of genes involved in the angiogenesis regulation
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Study Chair: Nicolas PENEL, MD, Centre Oscar Lambret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000441642
  • FRE-FNCLCC-SARCOME-06/0409
  • EU-20517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be shared at an individual level.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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