AngiosarcomaPhase 2ANGIO-TAX+NCT01303497
Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas
A Phase 2 study testing Paclitaxel and Bevacizumab in people with Angiosarcoma, run by Centre Oscar Lambret at 13 sites in France.
Trial summary
Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiosarcoma
- What is being tested?
- Paclitaxel and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 13 sitesFrance
- Study dates
- 10 Sep 2010to 29 Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Angiosarcoma histologically proven
- Metastatic or locally advanced and not accessible to surgery treatment
- Measurable tumor with at least 1 measurable lesion, according to RECIST
- For angiosarcoma in irradiated region, absence of clinical arguments of progression of the tumor prior treated by radiation
- At least 28 days since the previous treatment (systemic or major surgery)
- Performance Status (ECOG) ≤ 1
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- Man or woman >= 18 years
- Polynuclear neutrophils >1500/mm3, platelets > 100 000/ mm3, Hemoglobin > 9.0 g/dl
- Total bilirubin ≤ 1.5 x USL, AST and ALT ≤ 2.5 x USL (or ≤ 5 if hepatic metastasis )
- Serum creatinin ≤ 1.5 x USL or clearance calculated > 50 ml/mn (Cockcroft formulae)
- Absence of hematuria on dipstick
- Proteinuria on dipstick <2+, if >2, the 24 hours proteinuria must be < 1g
- Albumin > 35 g/l and lymphocytes > 700/mm3 attesting a life expectancy > 3 months
- Normal cardiac function : LVEF ≥ 50%
- Normal coagulation test : INR ≤ 1.5 and TCA ≤ 1.5 x USL within 7 days before inclusion
- Systolic BP ≤ 150 mmHg and diastolic BP ≤ 100 mmHg
- Negative pregnancy test for women of reproductive potential(within 7 days before treatment start)
- Effective contraceptive methods for male and female (if applicable) during the period of treatment and until the 6 months after the last administration of Bevacizumab
- Adequate central veinous access
- Patient covered by government health insurance
- Informed consent form signed by the patient
Who cannot join
- Patients that have received more than 2 regimens of chemotherapy whatever the indication
- Kaposi's sarcoma, hemangio-endothelioma, hemangio-pericytoma (Malignant solitary fibrous tumor)
- Surgery (except the diagnostic biopsy) or radiotherapy within the past 4 weeks before inclusion, except antalgic radiotherapy
- Uncontrolled, active peptic ulcer,
- Other malignant evolutive tumor
- Previous thrombotic or hemorrhagic disorders
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- Clinically significant cardiovascular disease (stroke within 6 months prior inclusion, unstable angina, heart failure, myocardial infarction, arrhythmia requiring treatment)
- Anticoagulant treatment for curative aim within 10 days before beginning of treatment (oral or parenteral administration), aspirin > 325 mg/day, or Plavix or a thrombolytic (thrombolytics for preventive use is permitted) or anti-platelet (dipyridamol, ticlopidine, clodiprogel, cilostazol)
- Chronic treatment(more than 15 days) by every AINS including aspirin > 325 mg/j
- Currently active bacterial or fungus infection (grade > 2 CTCAE v4.02)
- Known HIV1, HIV2, hepatitis B or hepatitis C infections
- Presence of known meningeal or brain metastasis
- Epilepsy requiring the use of anti-epileptic
- Previous organ transplant
- Peripheral stem cell transplantation within 4 months prior to inclusion in the study
- Using of drugs affecting the biological response, for example G-CSF, within the 3 weeks before inclusion
- Kidney dialysis patient
- Clinically significant neuropathy (grade> 2 CTCAE V4.02)
- Any circumstance that could jeopardise compliance or proper follow-up during the trial
- Pregnant or nursing women. Women should not breastfeed for at least 6 months after the last administration of Bevacizumab
- Constitutional or acquired coagulopathy
- Uncontrolled hypertension (SBP> 150 mmHg or DBP> 100 mmHg)
- Known hypersensitivity to paclitaxel or to one of its excipients (Cremophor EL, to Bevacizumab components, to products of Chinese hamster ovary cells (CHO) or other recombinant human or humanized antibodies
- Patients unable to undergo trail medical follow-up for geographical, social or psychological reasons
- Patient refusal of ambulatory care
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Institut Bergonié
Bordeaux, 33076
Centre François Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Georges François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69008
Centre Val d'Aurelle
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Institut Curie
Paris, 75005
Centre René Gauducheau
Saint-Herblain, 44805
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270
Institut Claudius Regaud
Toulouse, 31052
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Phase II Study, Multicenter, Randomized, Stratified, Evaluating the Efficacity of Weekly Paclitaxel, With or Without Bevacizumab in the Treatment of Metastatic or Locally Advanced Angiosarcomas Not Accessible to Surgery Treatment.
Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma
Read the detailed description
Randomization is stratified :
- angiosarcoma in irradiated region : yes / no
- visceral angiosarcoma : yes / no
All patient will received a maximum of 6 cycles of weekly Paclitaxel (Arm A and B) in association or not with Bevacizumab (ArmB).
1 cycle = 28 days Treatment by Bevacizumab is to continue beyond the 6th cycle, until disease progression or unacceptable toxicity
Arm A and B:
Day 1, D8 and D15 Paclitaxel : 90 mg/m², IV weekly with premedication
Arm B :
Day 1 and D15 Bevacizumab : 10 mg/kg and then, Bevacizumab : 15 mg/kg/3 weeks until disease progression or unacceptable toxicity
- Conditions
- Angiosarcoma
- Being tested
- Paclitaxel, Bevacizumab
- Keywords
- Angiosarcoma, Paclitaxel, bevacizumab
- Medical subject headings
- Hemangiosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
Day 1, 8 and 15 : Paclitaxel 90 mg/m², IV over 1h, during 6 cycles (1 cycle = 28 days)
BevacizumabDrug
Also called Avastin
Bevacizumab until progression or inacceptable toxicity :
- During the cycles of chemotherapy : Day 1 and D15 : 10 mg/kg,IV
- After 6 cycles of chemotherapy : 15 mg/kg, IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Paclitaxel | Other | administration of paclitaxel drug during cycle of 28 days (6 cycles Max) + blood sample on day 1, 8, 15, 29 and 57 Receives: Drug: Paclitaxel |
| Arm B : Paclitaxel + Bevacizumab | Other | administration of paclitaxel drug during per cycle of 28 days (6 cycles Max) + Bevacizumab every two weeks during paclitaxel cycles then every 3 weeks during P cycles until disease progression or inacceptable toxicity
+ blood sample on day 1, 8, 15, 29 and 57 Receives: Drug: Paclitaxel; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free rate after 6 months of treatment
Stable disease, complete response and partial response according to RECIST 1.1
Measured: after 6 months of treatment
Secondary outcomes (6)
Objective response at 3, 6, 9 months of treatment
Stable disease, complete response and partial response according to RECIST 1.1
Measured: at 3, 6, 9 months of treatment
Median progression-free rate
Median time for both cohort between :
- date of inclusion
- date of clinical or radiological progression
Measured: an average time period of 1 year
Global median survival
Median time for both cohort between :
- date of inclusion
- date of death whatever the cause
Measured: an average time period of 18 months
Tolerance
According to NCI-CTCAE v4.0
Measured: during the study
Correlation between efficacity and serum expression of anti angiogenic factors
Blood samples at different times
Measured: Day 1, 8, 15, 29 and 57
Correlation between efficacity and beta-tubuline III expression in tissue
Paraffin blocks
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study start10 Sep 2010
- Primary completionApr 2014
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AngiosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- French Sarcoma Group, Study Group of Bone Tumors
- Responsible party
- Sponsor
- Investigators
- Nicolas PENEL, MD, PhD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303497
- Sponsor's protocol ID
- ANGIO-TAX-PLUS-0906
- Other IDs
- 2009-017020-59, 2009
- Acronym
- ANGIO-TAX+
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2011
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lebellec L, Bertucci F, Tresch-Bruneel E, Ray-Coquard I, Le Cesne A, Bompas E, Blay JY, Italiano A, Mir O, Ryckewaert T, Toiron Y, Camoin L, Goncalves A, Penel N, Le Deley MC. Prognostic and predictive factors for angiosarcoma patients receiving paclitaxel once weekly plus or minus bevacizumab: an ancillary study derived from a randomized clinical trial. BMC Cancer. 2018 Oct 11;18(1):963. doi: 10.1186/s12885-018-4828-1.
PubMed 30305054
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study, Multicenter, Randomized, Stratified, Evaluating the Efficacity of Weekly Paclitaxel, With or Without Bevacizumab in the Treatment of Metastatic or Locally Advanced Angiosarcomas Not Accessible to Surgery Treatment.
- ClinicalTrials.gov ID
- NCT01303497
- Acronym / sponsor ID
- ANGIO-TAX+ / ANGIO-TAX-PLUS-0906
- Conditions
- Angiosarcoma
- Keywords
- Angiosarcoma, Paclitaxel, bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- French Sarcoma Group, Study Group of Bone Tumors
- Study start
- 10 Sep 2010 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma
Detailed description
Randomization is stratified :
- angiosarcoma in irradiated region : yes / no
- visceral angiosarcoma : yes / no
All patient will received a maximum of 6 cycles of weekly Paclitaxel (Arm A and B) in association or not with Bevacizumab (ArmB).
1 cycle = 28 days Treatment by Bevacizumab is to continue beyond the 6th cycle, until disease progression or unacceptable toxicity
Arm A and B:
Day 1, D8 and D15 Paclitaxel : 90 mg/m², IV weekly with premedication
Arm B :
Day 1 and D15 Bevacizumab : 10 mg/kg and then, Bevacizumab : 15 mg/kg/3 weeks until disease progression or unacceptable toxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : Paclitaxel | Other | Drug: Paclitaxeladministration of paclitaxel drug during cycle of 28 days (6 cycles Max) + blood sample on day 1, 8, 15, 29 and 57 |
| Arm B : Paclitaxel + Bevacizumab | Other | Drug: Paclitaxel, Drug: Bevacizumabadministration of paclitaxel drug during per cycle of 28 days (6 cycles Max) + Bevacizumab every two weeks during paclitaxel cycles then every 3 weeks during P cycles until disease progression or inacceptable toxicity + blood sample on day 1, 8, 15, 29 and 57 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Angiosarcoma histologically proven
- Metastatic or locally advanced and not accessible to surgery treatment
- Measurable tumor with at least 1 measurable lesion, according to RECIST
- For angiosarcoma in irradiated region, absence of clinical arguments of progression of the tumor prior treated by radiation
- At least 28 days since the previous treatment (systemic or major surgery)
Key exclusion criteria (25 listed)
- Patients that have received more than 2 regimens of chemotherapy whatever the indication
- Kaposi's sarcoma, hemangio-endothelioma, hemangio-pericytoma (Malignant solitary fibrous tumor)
- Surgery (except the diagnostic biopsy) or radiotherapy within the past 4 weeks before inclusion, except antalgic radiotherapy
- Uncontrolled, active peptic ulcer,
- Other malignant evolutive tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelAlso: TaxolDay 1, 8 and 15 : Paclitaxel 90 mg/m², IV over 1h, during 6 cycles (1 cycle = 28 days) | Drug | Arm A : Paclitaxel, Arm B : Paclitaxel + Bevacizumab |
| BevacizumabAlso: AvastinBevacizumab until progression or inacceptable toxicity : * During the cycles of chemotherapy : Day 1 and D15 : 10 mg/kg,IV * After 6 cycles of chemotherapy : 15 mg/kg, IV | Drug | Arm B : Paclitaxel + Bevacizumab |
Primary outcome
Progression free rate after 6 months of treatment
Time frame: after 6 months of treatment
Stable disease, complete response and partial response according to RECIST 1.1
6 secondary outcomes
Objective response at 3, 6, 9 months of treatment
Time frame: at 3, 6, 9 months of treatment
Median progression-free rate
Time frame: an average time period of 1 year
Global median survival
Time frame: an average time period of 18 months
Tolerance
Time frame: during the study
Correlation between efficacity and serum expression of anti angiogenic factors
Time frame: Day 1, 8, 15, 29 and 57
Correlation between efficacity and beta-tubuline III expression in tissue
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Derived from this study: PubMed 30305054Lebellec L, Bertucci F, Tresch-Bruneel E, Ray-Coquard I, Le Cesne A, Bompas E, Blay JY, Italiano A, Mir O, Ryckewaert T, Toiron Y, Camoin L, Goncalves A, Penel N, Le Deley MC. Prognostic and predictive factors for angiosarcoma patients receiving paclitaxel once weekly plus or minus bevacizumab: an ancillary study derived from a randomized clinical trial. BMC Cancer. 2018 Oct 11;18(1):963. doi: 10.1186/s12885-018-4828-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas PENEL, MD, PhD principal investigator
Centre Oscar Lambret
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel and Bevacizumab in people with Angiosarcoma, run by Centre Oscar Lambret at 13 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?
The sponsor lists 21 inclusion and 25 exclusion criteria. 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Progression free rate after 6 months of treatment (time frame: after 6 months of treatment). 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 NCT01303497, 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 13 Mar 2026.