Study comparing efficacy of doxorubicin with trabectedin followed by trabectedin in non-progressive patients versus doxorubicine alone as first-line therapy in patients with metastatic or unresectable leiomyosarcoma (uterine or soft tissue)
- Conditions
- Patients With Metastatic or Relapsed Unresectable Uterine or Soft Tissue LeiomyosarcomaMedDRA version: 19.0Level: PTClassification code 10024191Term: Leiomyosarcoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10046799Term: Uterine leiomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002186-56-FR
- Lead Sponsor
- GUSTAVE ROUSSY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
1. Patients must have histologically confirmed diagnosis of metastatic or or relapsed, unresectable uterine or soft tissue leiomyosarcoma, reviewed in a reference center (among RREPS network), previously untreated with chemotherapy , and with available Formalin Fixed Paraffin Embedded (FFPE) blocks
2. At least one measurable lesion according to RECIST V 1.1 criteria. Target could be in a previously irradiated field but has to be progressive or a biopsy had to be positive before inclusion.
3. Age = 18 years old
4. ECOG performance status < 2
5. Adequate haematological, liver and cardiac functions as defined in the protocol
6. Creatinin phosphokinase (CPK) = 2.5 x ULN
7. Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to inclusion. Both males and WOCBP who are sexually active should be using an effective birth control method from inclusion (for WOCBP) or treatment initiation (for male) and up to 6 months following the last dose of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. All other histological types of uterine sarcomas or soft tissue sarcomas
2. Any contraindication for the use of trabectedin and/or doxorubicin (cardiac, renal, hepatic, known hypersensitivity…)
3. History of another type of cancer not in complete remission for more than 3 years prior to study entry (except for cutaneous basal cell carcinoma or in situ cervical epithelioma), and/or having required any chemotherapy treatment at any time.
4. Known cerebral metastasis
5. History of allograft or autograft
6. Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine and compare the progression-free survival (PFS) of patients treated in first line with doxorubicin alone or with the association of doxorubicin and trabectedin followed by trabectedin for non-progressive patients;Secondary Objective: Determine and compare for each arm :<br>1. Clinical benefice rate <br>2. Response rate <br>3. Duration of response <br>4. Toxicities. <br>5. Overall survival of patients<br>6. Progression-free survival in second line therapy (PFS2) after progression<br>;Primary end point(s): RECIST 1.1;Timepoint(s) of evaluation of this end point: At baseline, <br>Every 6 weeks while on treatment period, <br>Every 9 weeks while on maintenance period or follow up period.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): RECIST 1.1<br>NCI CTCAE Version 4;Timepoint(s) of evaluation of this end point: 1. 2. 3. At baseline and then every 6 weeks up to 6 cycles of treatment.<br>4. All along the study<br>5. All along the study until patient death (including long term follow-up)<br>6. All along the study until progression under second line therapy