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

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Disease Information

Descriptive Information
Brief Title † Study of Doxorubicin and Trabectedin in First Line Treatment on Patients With Metastatic Leiomyosarcoma
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
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.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Disease control rate
Secondary Outcome Measure † Response rate
Condition † Uterus Leiomyosarcoma Soft Tissue Leiomyosarcoma
Intervention † DrugDoxorubicin
Study Arms / Comparison Groups Soft tissue Uterus
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 110
Start Date † June 2010
Completion Date October 2016
Primary Completion Date January 2013
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 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
Gender All
Ages 18 Years - 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † France
Administrative Information
NCT ID † NCT02131480
Organization ID 2009-012430-70
Secondary IDs †† 2008/1485
Responsible Party Sponsor
Study Sponsor † Gustave Roussy, Cancer Campus, Grand Paris
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date January 2017
First Received Date † May 5, 2014
Last Updated Date January 25, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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