A Study of AVE8062 in Advancedstage Soft Tissue Sarcoma After Failure of Anthracycline and Ifosfamide Chemotherapies

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

- Histologically proven STS at the first diagnosis. - Patients with advanced-stage STS: unresectable locally advanced STS or metastatic STS - Failure of a previous anthracycline-based regimen administered at recommended dose and of prior ifosfamide therapy - Disease progression within 1 month before study randomization
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Patient consent form not obtained, signed and dated - < 18 years old - ECOG Performance Status (PS) > 2 - Life expectancy < 12 weeks. - Brain metastases and carcinomatous leptomeningitis. - >2 previous chemotherapy regimens for advanced disease. - Prior intensive chemotherapy with autologous stem cell rescue - Prior treatment with Tyrosine Kinase inhibitors (TKI) - History of other cancer. Adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for > 5 years are allowed. - Only lesions previously irradiated (i.e. lesions not evaluable) if no other evaluable lesions are present. At study entry, in the case of one single metastatic target lesion, histological or cytological proof to metastasis should be obtained. - Pregnant or breast-feeding women. Positive serum or urine pregnancy test for women prior to randomization - Patients with reproductive potential (M/F) who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 3 months after the completion of the study treatment. Female partners of male patient must follow the same contraceptive methods as mentioned above. - Washout period of at least 3 weeks from prior anti-tumor therapy (chemotherapy, targeted agents, and radiotherapy) or any investigational treatment, except for nitrosoureas, mitomycin C which may not be used up to 6 weeks prior to the randomization date provided that patients do not have residual signs of any toxicity. - Complete initial work up earlier than 3 weeks prior to patient randomization. - Patient's inability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. - Concurrent treatment with any other anticancer therapy - Other severe illness or medical conditions (see protocol) - Patient with LVEF < 50 % for institution inferior normal limit, evaluated by echocardiography, or by radionuclide assessment. - Ischemic event within 1 year prior to study entry -Uncontrolled hypertension - Uncontrolled arrhythmia particularly severe conduction disorder such as second or third-degree atrio-ventricular block - Thrombo-embolism requiring anticoagulants within the past 6 months - Organ function as follows: 1. Blood marrow: neutrophils < 1.5 x 109/L; platelets <100 x 109/L 2. Kidney function: creatinine > 1.5 mg/dl. If creatinine = 1.5 mg/dl, the calculated creatinine clearance should be = 60 ml/min 3. Liver function: Total bilirubin value > normal limit; ALT/AST/AP = 2.5 times the upper NR- increase of AP (= grade 2) would be accepted only if this increase is related to the presence of bone metastases. 4. Known platinum hypersensitivity 5. Current peripheral neuropathy > grade 1 according to the NCI CTCAE classification, of any origin including symptoms due to the use of neurotoxic drugs (e.g. vinca-alkaloids, platinum or taxans)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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