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

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ClinicalTrials.gov Identifier: NCT01303497
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
French Sarcoma Group
Study Group of Bone Tumors
Information provided by (Responsible Party):
Centre Oscar Lambret

Tracking Information
First Submitted Date  ICMJE February 23, 2011
First Posted Date  ICMJE February 24, 2011
Last Update Posted Date May 30, 2019
Actual Study Start Date  ICMJE September 10, 2010
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacity of Weekly Paclitaxel in Association or Not With Bevacizumab in Metastatic or Locally Advanced Angiosarcomas
Official Title  ICMJE 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.
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Angiosarcoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 23, 2011)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 29, 2019
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01303497
Other Study ID Numbers  ICMJE ANGIO-TAX-PLUS-0906
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Oscar Lambret
Study Sponsor  ICMJE Centre Oscar Lambret
Collaborators  ICMJE
  • French Sarcoma Group
  • Study Group of Bone Tumors
Investigators  ICMJE
Principal Investigator: Nicolas PENEL, MD, PhD Centre Oscar Lambret
PRS Account Centre Oscar Lambret
Verification Date January 2017

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