AzTrials
AzTrials

SarcomaPhase 2NCT00217607

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

A Phase 2 study testing paclitaxel in people with Sarcoma, run by UNICANCER at 23 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Sarcoma
What is being tested?
paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
23 sitesFrance
Study dates
Feb 2005to Jan 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

France23 sites

  • Centre Paul Papin

    Angers, 49036

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot - Lyon

    Lyon, 69437

  • CHU de la Timone

    Marseille, 13385

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Centre Regional Rene Gauducheau

    Nantes-Saint Herblain, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie Hopital

    Paris, 75248

  • Hopital Cochin

    Paris, 75674

  • Centre Eugene Marquis

    Rennes, 35042

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Sarcoma
Being tested
paclitaxel
Keywords
adult angiosarcoma, recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
Medical subject headings
Sarcoma, Hemangiosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00217607
Study groupRoleWhat they receive
PaclitaxelExperimentalPaclitaxel 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)
Receives: Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Measured: 2 months

Secondary outcomes (7)

  1. Response rate

    Measured: 4 months

  2. Response rate

    Measured: 6 months

  3. Tolerability

    Measured: 6 months

  4. Time to progression

    Measured: 5 years

  5. Overall survival

    Measured: 5 years

  6. Clinical criteria predicting response

    Measured: 2 months

  7. Correlation of efficacy with the expression of genes involved in the angiogenesis regulation

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionApr 2008
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00217607
Sponsor's protocol ID
CDR0000441642
Other IDs
FRE-FNCLCC-SARCOME-06/0409, EU-20517
Status last verified
Aug 2016
First submitted
20 Sep 2005
Last updated
30 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Individual participant data will not be shared at an individual level.

Publications

  • 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.

    PubMed 18809609

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing paclitaxel in people with Sarcoma, run by UNICANCER at 23 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00217607, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in