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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Uterus Leiomyosarcoma Soft Tissue Leiomyosarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Soft tissue

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

60 mg/m²

Trabectedin

Intervention Type DRUG

1,1 mg/m²

Uterus

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

60 mg/m²

Trabectedin

Intervention Type DRUG

1,1 mg/m²

Interventions

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Doxorubicin

60 mg/m²

Intervention Type DRUG

Trabectedin

1,1 mg/m²

Intervention Type DRUG

Other Intervention Names

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Adriamycin Yondelis®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No