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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
paclitaxel
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring adult angiosarcoma, recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Paul Papin
  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
  • Institut Bergonie
  • Centre Regional Francois Baclesse
  • Centre Jean Perrin
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  • Centre Oscar Lambret
  • Centre Leon Berard
  • Hopital Edouard Herriot - Lyon
  • CHU de la Timone
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Regional Rene Gauducheau
  • Centre Antoine Lacassagne
  • Institut Curie Hopital
  • Hopital Cochin
  • Centre Eugene Marquis
  • Hopital Charles Nicolle
  • Centre Henri Becquerel
  • Centre Rene Huguenin
  • Institut de Cancerologie de la Loire
  • Institut Claudius Regaud
  • Centre Hospitalier Universitaire Bretonneau de Tours
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel

Arm Description

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)

Outcomes

Primary Outcome Measures

Objective Response Rate

Secondary Outcome Measures

Response rate
Response rate
Tolerability
Time to progression
Overall survival
Clinical criteria predicting response
Correlation of efficacy with the expression of genes involved in the angiogenesis regulation

Full Information

First Posted
September 20, 2005
Last Updated
August 29, 2016
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00217607
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
adult angiosarcoma, recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
4 months
Title
Response rate
Time Frame
6 months
Title
Tolerability
Time Frame
6 months
Title
Time to progression
Time Frame
5 years
Title
Overall survival
Time Frame
5 years
Title
Clinical criteria predicting response
Time Frame
2 months
Title
Correlation of efficacy with the expression of genes involved in the angiogenesis regulation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Penel, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Edouard Herriot - Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
Institut de Cancerologie de la Loire
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Hospitalier Universitaire Bretonneau de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared at an individual level.
Citations:
PubMed Identifier
18809609
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.
Results Reference
result

Learn more about this trial

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

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