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

Primary Purpose

Uterus Leiomyosarcoma, Soft Tissue Leiomyosarcoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Doxorubicin
Trabectedin
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterus Leiomyosarcoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gustave Roussy Cancer Campus Grand Paris

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Soft tissue

Uterus

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response rate
Assessed using RECIST criteria
Progression Free Survival

Full Information

First Posted
May 5, 2014
Last Updated
January 25, 2017
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02131480
Brief Title
Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma
Acronym
LMS02
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterus Leiomyosarcoma, Soft Tissue Leiomyosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soft tissue
Arm Type
Experimental
Arm Title
Uterus
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin
Intervention Description
60 mg/m²
Intervention Type
Drug
Intervention Name(s)
Trabectedin
Other Intervention Name(s)
Yondelis®
Intervention Description
1,1 mg/m²
Primary Outcome Measure Information:
Title
Disease control rate
Description
Disease control rate (objective response + stability) as defined by RECIST criteria
Time Frame
Assessed every 6 weeks from inclusion up to 6 months
Secondary Outcome Measure Information:
Title
Response rate
Description
Assessed using RECIST criteria
Time Frame
Assessed every 6 weeks from inclusion up to 6 months
Title
Progression Free Survival
Time Frame
Assessed every 6 weeks from inclusion up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gustave Roussy Cancer Campus Grand Paris
City
Villejuif
State/Province
Val de Marne
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34325109
Citation
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.
Results Reference
derived
PubMed Identifier
25795402
Citation
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.
Results Reference
derived

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

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