Clinical trial NCT00217607: Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Keywords: adult angiosarcoma
recurrent adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 2 months
Secondary outcomes:
measure: Response rate
timeFrame: 4 months
measure: Response rate
timeFrame: 6 months
measure: Tolerability
timeFrame: 6 months
measure: Time to progression
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Clinical criteria predicting response
timeFrame: 2 months
measure: Correlation of efficacy with the expression of genes involved in the angiogenesis regulation
timeFrame: 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Besancon
country: France
facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Hopital Edouard Herriot - Lyon
city: Marseille
country: France
facility: CHU de la Timone
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Nantes-Saint Herblain
country: France
facility: Centre Regional Rene Gauducheau
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie Hopital
city: Paris
country: France
facility: Hopital Cochin
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: Saint Priest en Jarez
country: France
facility: Institut de Cancerologie de la Loire
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Tours
country: France
facility: Centre Hospitalier Universitaire Bretonneau de Tours
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Oscar Lambret
name: Nicolas Penel, MD
role: STUDY_CHAIR
References:
citation: 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 ANGIOTAX Study. J Clin Oncol. 2008 Nov 10;26(32):5269-74. doi: 10.1200/JCO.2008.17.3146. Epub 2008 Sep 22.