- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02131480
Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma (LMS02)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Val de Marne
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Villejuif, Val de Marne, France, 94805
- Gustave Roussy Cancer Campus Grand Paris
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Soft tissue
|
60 mg/m²
Other Names:
1,1 mg/m²
Other Names:
|
Experimental: Uterus
|
60 mg/m²
Other Names:
1,1 mg/m²
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Assessed every 6 weeks from inclusion up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: Assessed every 6 weeks from inclusion up to 6 months
|
Assessed using RECIST criteria
|
Assessed every 6 weeks from inclusion up to 6 months
|
Progression Free Survival
Time Frame: Assessed every 6 weeks from inclusion up to 12 weeks
|
Assessed every 6 weeks from inclusion up to 12 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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. A single-arm multicentre phase II trial of doxorubicin in combination with trabectedin in the first-line treatment for leiomyosarcoma with long-term follow-up and impact of cytoreductive surgery. ESMO Open. 2021 Aug;6(4):100209. doi: 10.1016/j.esmoop.2021.100209. Epub 2021 Jul 26.
- 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, Soulie P, Toulmonde M, Le Cesne A, Lacas B, Duffaud F; French Sarcoma Group. 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. Lancet Oncol. 2015 Apr;16(4):457-64. doi: 10.1016/S1470-2045(15)70070-7. Epub 2015 Mar 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Neoplasms, Muscle Tissue
- Leiomyosarcoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Trabectedin
Other Study ID Numbers
- 2009-012430-70
- 2008/1485 (Other Identifier: CSET number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uterus Leiomyosarcoma
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IgenomixRecruitingLeiomyoma, Uterine | Leiomyosarcoma UterusSpain
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingLocally Advanced Leiomyosarcoma | Metastatic Leiomyosarcoma | Stage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Unresectable Leiomyosarcoma | Uterine Corpus LeiomyosarcomaUnited States
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Frederic AmantKom Op Tegen Kanker; FWO Research Fund FlandersRecruitingEndometrial Cancer | Endometrial Stromal Sarcoma | Sex Cord Stromal Tumor | Adenosarcoma of Uterus | Leiomyosarcoma Uterus | Serous Ovarian TumorBelgium
-
National Cancer Institute (NCI)RecruitingLocally Advanced Uterine Corpus Leiomyosarcoma | Metastatic Uterine Corpus Leiomyosarcoma | Stage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Unresectable Uterine Corpus LeiomyosarcomaUnited States, Puerto Rico
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Ain Shams Maternity HospitalCompleted
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Kristen GanjooRecruitingUterine Leiomyosarcoma | LMS - LeiomyosarcomaUnited States
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Mashhad University of Medical SciencesCompletedUterus Contractions Pattern
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