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Completed

NCT Number: NCT02131480

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

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.

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Key information

Conditions

Uterus Leiomyosarcoma Soft Tissue Leiomyosarcoma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxorubicin

Drug

60 mg/m²

Other names: Adriamycin

Trabectedin

Drug

1,1 mg/m²

Other names: Yondelis®

Primary outcomes

  1. Disease control rate

    Time frame: Assessed every 6 weeks from inclusion up to 6 months

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

Secondary outcomes

  1. Response rate

    Time frame: Assessed every 6 weeks from inclusion up to 6 months

    Assessed using RECIST criteria

  2. Progression Free Survival

    Time frame: Assessed every 6 weeks from inclusion up to 12 weeks

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study 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

Acronym: LMS02

Important dates

Study start
2010
Primary completion
2013
Study completion
2016
First posted
May 6, 2014
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.