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

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: March 6, 2014
Last verified: June 2012
  Purpose

Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma


Condition Intervention Phase
Angiosarcoma
Paclitaxel
Drug: Paclitaxel
Drug: Bevacizumab
Procedure: Blood samples
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study, Multicenter, Randomized, Stratified, Evaluating the Efficacity of Weekly Paclitaxel, in Association or Not With 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    Median time for both cohort between :

    • date of inclusion
    • date of death wathever the cause

  • Tolerance [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Blood samples at different times

  • Correlation between efficacity and beta-tubuline III expression in tissue [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Paraffin blocks


Estimated Enrollment: 70
Study Start Date: September 2010
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A : Paclitaxel Drug: Paclitaxel
Day 1, 8 and 15 : Paclitaxel 90 mg/m², IV over 1h, during 6 cycles (1 cycle = 28 days)
Procedure: Blood samples

Blood samples at different times :

  • Day 1
  • Day 8
  • Day 15
  • Day 29
  • Day 57
Arm B : Paclitaxel + Bevacizumab Drug: Paclitaxel
Day 1, 8 and 15 : Paclitaxel 90 mg/m², IV over 1h, during 6 cycles (1 cycle = 28 days)
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
Procedure: Blood samples

Blood samples at different times :

  • Day 1
  • Day 8
  • Day 15
  • Day 29
  • Day 57

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
Genders Eligible for Study:   Both
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
Paoli Calmettes Institut
Marseille, France, 13273
Centre Val d'Aurelle
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
Institut Curie
Paris, France, 75005
TENON Hospital
Paris, France, 75020
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

No publications provided

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: March 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Oscar Lambret:
Angiosarcoma
Paclitaxel
bevacizumab

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

ClinicalTrials.gov processed this record on October 22, 2014