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

Phase 2

Completed

• Conditions: Sarcoma
• Interventions: Drug: paclitaxel

• Registration Number: NCT00217607
• Lead Sponsor: UNICANCER

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.

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 Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2008-04
• Study Completion: 2012-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel	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)

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	2 months

Secondary Outcome Measures

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

Trial Locations

Locations (23)

Centre Hospitalier Universitaire Bretonneau de Tours; 🇫🇷 Tours, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz; 🇫🇷 Besancon, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Paul Papin; 🇫🇷 Angers, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Centre de Lutte Contre le Cancer Georges-Francois Leclerc; 🇫🇷 Dijon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Hopital Edouard Herriot - Lyon; 🇫🇷 Lyon, France

Centre Leon Berard; 🇫🇷 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

Centre Eugene Marquis; 🇫🇷 Rennes, France

Hopital Cochin; 🇫🇷 Paris, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Hopital Charles Nicolle; 🇫🇷 Rouen, France

Institut de Cancerologie de la Loire; 🇫🇷 Saint Priest en Jarez, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France