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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:
Collaborators:
Groupe Sarcome Français
Groupe d’études des Tumeurs Osseuses
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01303497
First received: February 23, 2011
Last updated: January 11, 2017
Last verified: January 2017
  Purpose
Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma

Condition Intervention Phase
Angiosarcoma
Drug: Paclitaxel
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 70
Study Start Date: September 2010
Estimated Study Completion Date: June 2017
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Paclitaxel
Day 1, 8 and 15 : Paclitaxel 90 mg/m², IV over 1h, during 6 cycles (1 cycle = 28 days)
Other Name: Taxol
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

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303497

Locations
France
Institut Bergonié
Bordeaux, France, 33076
Centre François Baclesse
Caen, France, 14076
Centre Jean Perrin
Clermont Ferrand, France, 63011
Centre Georges François Leclerc
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
Centre Léon Bérard
Lyon, France, 69008
Centre Val d'Aurelle
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
Institut Curie
Paris, France, 75005
Centre René Gauducheau
Saint Herblain, France, 44805
Institut de Cancérologie de la Loire
SAINT PRIEST en JAREZ, France, 42270
Institut Claudius Regaud
Toulouse, France, 31052
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Oscar Lambret
Groupe Sarcome Français
Groupe d’études des Tumeurs Osseuses
Investigators
Principal Investigator: Nicolas PENEL, MD, PhD Centre Oscar Lambret
  More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01303497     History of Changes
Other Study ID Numbers: ANGIO-TAX-PLUS-0906
Study First Received: February 23, 2011
Last Updated: January 11, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Centre Oscar Lambret:
Angiosarcoma
Paclitaxel
bevacizumab

Additional relevant MeSH terms:
Hemangiosarcoma
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on March 29, 2017