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LMS02: Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris (Other)
Overall Status
Completed
CT.gov ID
NCT02131480
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
76
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin, ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft tissue.

The trabectedin is a new cancer drug that has obtained marketing authorization after failure of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.

This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin in first-line treatment of uterine or soft tissue leiomyosarcoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicentric Phase II Trial Studying Efficacy of Doxorubicin Associated With Trabectedin (Yondelis) in First Line Treatment on Patients With Metastatic Leiomyosarcoma (Uterus or Soft Tissue) and/or Inoperable Relapse
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Soft tissue

Drug: Doxorubicin
60 mg/m²
Other Names:
  • Adriamycin

    • Drug: Trabectedin
    1,1 mg/m²
    Other Names:
  • Yondelis®

    		•
    Experimental: Uterus

    Drug: Doxorubicin
    60 mg/m²
    Other Names:
  • Adriamycin

    • Drug: Trabectedin
    1,1 mg/m²
    Other Names:
  • Yondelis®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease control rate [Assessed every 6 weeks from inclusion up to 6 months]

      Disease control rate (objective response + stability) as defined by RECIST criteria

    Secondary Outcome Measures

    1. Response rate [Assessed every 6 weeks from inclusion up to 6 months]

      Assessed using RECIST criteria

    2. Progression Free Survival [Assessed every 6 weeks from inclusion up to 12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Metastatic leiomyosarcoma (uterus or soft tissue) in inoperable relapse with no previous chemotherapy

    • At least one measurable lesion according to RECIST criteria before inclusion. At least one of the target is in a none irradiated area

    • Aged >/= 18 years and physiological age </= 70 years

    • PS </= 2

    • Normal hematological function (Polymorphonuclear Neutrophils >/= 1500/mm3, platelets

    /= 100 000/mm3)

    • Normal kidney function (creatinine < 1.5xN)

    • Creatinine phosphokinase </= 2.5xN

    • Normal hepatic function (total bilirubin </= 1xN; transaminase </= 2.5xN and alkaline phosphatase </= 1.5xN)

    • Cardiac function: normal echography and/or isotopic ventriculography (FR>30%, FEVG > 50%)

    • Patients able to procreate must use a birth control device during treatment and during 3 months after treatment for women; 5 months for men

    • Signed informed consent

    • Patient under affiliated to a system of care

    Exclusion Criteria:

    • Any other histological type of uterus sarcoma (carcinosarcoma...) or soft tissue

    • Specific contraindication to the treatment

    • Previous or evolutive mental disease

    • Previous cancer

    • Symptomatic or known brain metastasis

    • Previous radiotherapy ont he only measurable lesion

    • Previous allograft or autograft

    • Known positive serology (HIV, HbC, HbS)

    • Pregnant or breastfeeding women

    • Impossibility to follow the treatment for geographical, social or mental reason

    • Patients under legal protection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gustave Roussy Cancer Campus Grand Paris Villejuif Val de Marne France 94805

    Sponsors and Collaborators

    • Gustave Roussy, Cancer Campus, Grand Paris

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gustave Roussy, Cancer Campus, Grand Paris
    ClinicalTrials.gov Identifier:
    NCT02131480
    Other Study ID Numbers:
    • 2009-012430-70
    • 2008/1485
    First Posted:
    May 6, 2014
    Last Update Posted:
    Jan 26, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Leiomyosarcoma
    Doxorubicin
    Trabectedin

    Study Results

    No Results Posted as of Jan 26, 2017