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Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas (ANGIO-TAX+)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01303497
First Posted: February 24, 2011
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Groupe Sarcome Français
Groupe d’études des Tumeurs Osseuses
Information provided by (Responsible Party):
Centre Oscar Lambret
February 23, 2011
February 24, 2011
January 12, 2017
September 2010
April 2014   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01303497 on ClinicalTrials.gov Archive Site
  • Objective response at 3, 6, 9 months of treatment [ Time Frame: at 3, 6, 9 months of treatment ]
    Stable disease, complete response and partial response according to RECIST 1.1
  • Median progression-free rate [ Time Frame: an average time period of 1 year ]

    Median time for both cohort between :

    • date of inclusion
    • date of clinical or radiological progression
  • Global median survival [ Time Frame: an average time period of 18 months ]

    Median time for both cohort between :

    • date of inclusion
    • date of death whatever the cause
  • Tolerance [ Time Frame: during the study ]
    According to NCI-CTCAE v4.0
  • Correlation between efficacity and serum expression of anti angiogenic factors [ Time Frame: Day 1, 8, 15, 29 and 57 ]
    Blood samples at different times
  • Correlation between efficacity and beta-tubuline III expression in tissue [ Time Frame: At baseline ]
    Paraffin blocks
  • Objective response at 3, 6, 9 months of treatment [ Time Frame: at 3, 6, 9 months of treatment ]
    Stable disease, complete response and partial response according to RECIST 1.1
  • Median progression-free rate [ Time Frame: Until disease progression ]

    Median time for both cohort between :

    • date of inclusion
    • date of clinical or radiological progression
  • Global median survival [ Time Frame: until death ]

    Median time for both cohort between :

    • date of inclusion
    • date of death wathever the cause
  • Tolerance [ Time Frame: Troughout the study ]
    According to NCI-CTCAE v4.0
  • Correlation between efficacity and serum expression of anti angiogenic factors [ Time Frame: Day 1, 8, 15, 29 and 57 ]
    Blood samples at different times
  • Correlation between efficacity and beta-tubuline III expression in tissue [ Time Frame: At baseline ]
    Paraffin blocks
Not Provided
Not Provided
 
Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas
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

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

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Angiosarcoma
  • Drug: Paclitaxel
    Day 1, 8 and 15 : Paclitaxel 90 mg/m², IV over 1h, during 6 cycles (1 cycle = 28 days)
    Other Name: Taxol
  • Drug: Bevacizumab

    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
    Other Name: Avastin
  • Arm A : Paclitaxel
    administration of paclitaxel drug during cycle of 28 days (6 cycles Max) + blood sample on day 1, 8, 15, 29 and 57
    Intervention: Drug: Paclitaxel
  • Arm B : Paclitaxel + Bevacizumab

    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

    Interventions:
    • Drug: Paclitaxel
    • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
June 2017
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01303497
ANGIO-TAX-PLUS-0906
Yes
Not Provided
Plan to Share IPD: No
Centre Oscar Lambret
Centre Oscar Lambret
  • Groupe Sarcome Français
  • Groupe d’études des Tumeurs Osseuses
Principal Investigator: Nicolas PENEL, MD, PhD Centre Oscar Lambret
Centre Oscar Lambret
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP