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

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217607
• Other study ID #: CDR0000441642
• Secondary ID: FRE-FNCLCC-SARCO
• Status: Completed
• Phase: Phase 2
• First received: September 20, 2005
• Last updated: August 29, 2016
• Start date: February 2005
• Est. completion date: January 2012

Study information

• Verified date: August 2016
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• paclitaxel

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz	Besancon
France	Institut Bergonie	Bordeaux
France	Centre Regional Francois Baclesse	Caen
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Hopital Edouard Herriot - Lyon	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	Hopital Cochin	Paris
France	Institut Curie Hopital	Paris
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Hopital Charles Nicolle	Rouen
France	Centre Rene Huguenin	Saint Cloud
France	Institut de Cancerologie de la Loire	Saint Priest en Jarez
France	Institut Claudius Regaud	Toulouse
France	Centre Hospitalier Universitaire Bretonneau de Tours	Tours
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (1)

Penel N, Bui BN, Bay JO, Cupissol D, Ray-Coquard I, Piperno-Neumann S, Kerbrat P, Fournier C, Taieb S, Jimenez M, Isambert N, Peyrade F, Chevreau C, Bompas E, Brain EG, Blay JY. Phase II trial of weekly paclitaxel for unresectable angiosarcoma: the ANGIOT — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate		2 months	No
Secondary	Response rate		4 months	No
Secondary	Response rate		6 months	No
Secondary	Tolerability		6 months	Yes
Secondary	Time to progression		5 years	No
Secondary	Overall survival		5 years	No
Secondary	Clinical criteria predicting response		2 months	No
Secondary	Correlation of efficacy with the expression of genes involved in the angiogenesis regulation		6 months	No