A study comparing the efficacy of the combination of doxorubicin and L19TNF to doxorubicin alone a in patients with advanced or metastatic soft tissue sarcoma

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 118

Inclusion Criteria

• Patients must have histological evidence of advanced unresectable and/or metastatic high-grade soft tissue sarcoma (grade 2 – 3 according to the FNCLCC grading system) not amenable to curative treatment with surgery or radiotherapy. The following tumor types are included:
–Malignant fibrous histiocytoma
–Myxoid and round cell liposarcoma, pleomorphic liposarcoma or dedifferentiated
–Liposarcoma
–Pleomorphic rhabdomyosarcoma
–Myxofibrosarcoma intermediate and high-grade
–Fibrosarcoma
–Leiomyosarcoma
–Angiosarcoma
–Alveolar rhabdomyosarcoma
–Unclassified sarcoma NOS

The following tumor types will not be included:
–GIST
–Mixed mesodermal tumor
–Chondrosarcoma
–Synovial sarcoma
–Malignant peripheral nerve sheath tumor
–Epithelioid sarcoma
–Embryonal rhabdomyosarcoma
–Malignant mesothelioma
–Neuroblastoma
–Osteosarcoma
–Ewing's sarcoma / primitive neuroectodermal tumor
–Desmoplastic small round cell tumor
–Alveolar soft part sarcoma
•Patients aged 18-75 years.
•No prior therapy (except surgery and radiation) for the advanced or metastatic stage of soft tissue sarcoma.
•Patients who had received prior anthracyclines will not be eligible.
•Patients must have at least one unidimensionally measurable lesion by computed tomography as defined by RECIST criteria 1.1. This lesion should not have been irradiated during previous treatments.
•Eastern Cooperative Oncology Group (ECOG) performance status of = 2.
•Life expectancy of at least 3 months.
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

1.Prior therapy (except surgery and radiation) for unresectable or metastatic malignant soft tissue sarcoma.
2.Previous treatment with anthracycline-containing chemotherapy.
3.Radiotherapy within 4 weeks prior therapy.
4.Known history of allergy to TNFa, anthracyclines or other intravenously administered human proteins/peptides/antibodies.
5.Absolute neutrophil count (ANC) < 1.5 x 109/L, platelets < 100 x 109/L and haemoglobin (Hb) < 9.0 g/dl.
6.Chronically impaired renal function as expressed by creatinine = 2.0 x ULN.
7.Inadequate liver function (ALT, AST, ALP or total bilirubin = 2.5 x ULN, except for patients with liver metastasis , in which case values up to 3.0 x ULN are allowed).
8.Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
9.History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
10.Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
11.Clinically significant cardiac arrhythmias or requiring permanent medication.
12.Uncontrolled hypertension, despite optimal therapy.
13.Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche-Fontaine classification).
14.Severe diabetic retinopathy such as severe non-proliferative retinopathy and proliferative retinopathy.
15.Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of study treatment.
16.Pregnancy or breast-feeding.
17.Requirement of chronic administration of corticosteroids or other immunosuppressant drugs. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.
18.Presence of active and uncontrolled infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
19.Known active or latent tuberculosis (TB).
20.Concurrent malignancies other than Soft Tissue Sarcoma, unless the patient has been disease-free for at least 2 years.
21.Growth factors or immunomodulatory agents within 7 days prior to the administration of study treatment.
22.Serious, non-healing wound, ulcer or bone fracture.
23.Allergy to study medication or excipients in study medication.
24.Concurrent therapy with oral anticoagulants .
25.Concurrent use of other anti-cancer treatments or agents other than study medication

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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