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

Conditions

Soft Tissue Leiomyosarcoma, Uterus Leiomyosarcoma

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.

Pautier P, Floquet A, Chevreau C, Penel N, Guillemet C, Delcambre C, Cupissol D, Selle F, Isambert N, Piperno-Neumann S, Saada-Bouzid E, Bertucci F, Bompas E, Alexandre J, Collard O, Lebrun-Ly V, Soulier P, Toulmonde M, Le Cesne A, Lacas B, Duffaud F, French Sarcoma Group.

2021-07-2618 citations

10.1016/j.esmoop.2021.100209

A single-arm multicenter phase II trial of doxorubicin (Doxo) in combination with trabectedin (Trab) given as first-line treatment to patients with metastatic/advanced uterine (U-LMS) and soft tissue leiomyosarcoma (ST-LMS): Final results of the LMS-02 study.

Patricia Pautier, Anne Floquet, Christine Chevreau, Nicolas Penel, Cécile Guillemet et al. (20 authors)

Journal of Clinical Oncology2020-05-202 citations

10.1200/jco.2020.38.15_suppl.11506

Trabectedin in combination with doxorubicin for first-line treatment of advanced uterine or soft-tissue leiomyosarcoma (LMS-02): a non-randomised, multicentre, phase 2 trial.

Pautier P, Floquet A, Chevreau C, Penel N, Guillemet C, Delcambre C, Cupissol D, Selle F, Isambert N, Piperno-Neumann S, Thyss A, Bertucci F, Bompas E, Alexandre J, Collard O, Lavau-Denes S, Soulié P, Toulmonde M, Le Cesne A, Lacas B, Duffaud F, French Sarcoma Group.

2015-03-1882 citations

10.1016/s1470-2045(15)70070-7

Interventions

DRUGDoxorubicin

60 mg/m²

DRUGTrabectedin

1,1 mg/m²

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Progression Free Survival	Assessed every 6 weeks from inclusion up to 12 weeks	—
Response rate	Assessed every 6 weeks from inclusion up to 6 months	Assessed using RECIST criteria

Countries

France

Outcome results

None listed