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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02131480
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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
Uterus Leiomyosarcoma Soft Tissue Leiomyosarcoma Drug: Doxorubicin Drug: Trabectedin Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : June 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: Soft tissue Drug: Doxorubicin
60 mg/m²
Other Name: Adriamycin

Drug: Trabectedin
1,1 mg/m²
Other Name: Yondelis®

Experimental: Uterus Drug: Doxorubicin
60 mg/m²
Other Name: Adriamycin

Drug: Trabectedin
1,1 mg/m²
Other Name: Yondelis®




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131480


Locations
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France
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT02131480    
Other Study ID Numbers: 2009-012430-70
2008/1485 ( Other Identifier: CSET number )
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Leiomyosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Doxorubicin
Trabectedin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents