Randomized phase II study of brostallicin (PNU-166196A) versus doxorubicin as first line chemotherapy in patients with advanced or metastatic soft tissue sarcoma

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

• Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or
intermediate grade, and of one of the following histologies (WHO classification 2002):
• Adipocytic (liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type,
not otherwise specified)
• Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid
fibrosarcoma)
• So-called fibrohistiocytic (pleomorphic Malignant Fibrous Histiocytoma (MFH), giant
cell *MFH*, inflammatory *MFH*)
• Leiomyosarcoma
• Malignant glomus tumors
• Skeletal muscles (rhabdomyosarcoma, alveolar or pleomorphic) excluding embryonal
rhabdomyosarcoma
• Vascular (epithelioid haemangioendothelioma, angiosarcoma)
• Uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell,
desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma,
perivascular epithelioid cell tumor (PEComa), intimal sarcoma) excluding
chondrosarcoma, Ewing tumors / Primitive neuroectodermal tumor (PNET)
• Malignant peripheral nerve sheath tumors
• Malignant solitary fibrous tumors
• Undifferentiated soft tissue sarcomas not otherwise specified
• Other types of sarcoma (not listed as ineligible), if approved by the Study Coordinator
(written or e-mail approval needed prior to registration)
• The following tumor types are ineligible:
• Embryonal rhabdomyosarcoma
• Chondrosarcoma
• Osteosarcoma
• Ewing tumors / PNET
• Gastro-intestinal stromal tumors
• Dermatofibrosarcoma protuberans
• Inflammatory myofibroblastic sarcoma
• Neuroblastoma
• Malignant mesothelioma
• Mixed mesodermal tumors of the uterus
• Formalin fixed paraffin embedded tumour blocks and representative H/E (haematoxylin/eosin) slides must be available for histological central review. Histological central review is not required before treatment start but is mandatory within 14 days of registration. Local histopathological diagnosis will be accepted for entry into the study.
• Relapsed, refractory and/or metastatic disease incurable by surgery or radiotherapy.
• Evidence of objective progression within the last 6 months (RECIST) documented by
measurements of disease, i.e. appearance of new lesions, increase of 20% in the sum of the diameters of measurable lesions, or progression of non measurable lesions to be confirmed by an external review, without other specific treatment since objective documentation of progression.
• Presence of measurable disease (according to RECIST criteria)
• No prior chemotherapy regimen for advanced or metastatic disease; (neo)adjuvant therapy is allowed.
• At least 60 years of age, or patients at least 18 years of age non suitable for intensive
chemotherapy combination treatments
• WHO performance status 0 or 1
• Absence of symptomatic or known CNS metastases
• Adequate bone marrow function (ANC> 2. 109/l, PLA>100 109/l )
• Adequate hepatic function (bilirubin <= 1.5 UNL , SGOT/AST <= 2.5 UNL and SGPT/ALT <= 2.5 UNL, Alk.phos <= 2.5 UNL)
• Adequate renal function: calculated or measured creatinine clearance >= 60 ml/min (see
Appendix C)
• Clinically normal cardiac function (LVEF assessed by MUGA or ECHO), normal 12 lead ECG, and in the past 6 months no serious cardiac illness or medical condition including but not confined to:
• History of documented congestive hear

Exclusion Criteria

The following tumor types are ineligible: . Embryonal rhabdomyosarcoma . Chondrosarcoma . Osteosarcoma . Ewing tumors / PNET . Gastro-intestinal stromal tumors . Dermatofibrosarcoma protuberans . Inflammatory myofibroblastic sarcoma . Neuroblastoma . Malignant mesothelioma . Mixed mesodermal tumors of the uterus.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary end-point: progression free survival 6 months (26 weeks) after start of<br /><br>treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary: overall progression free survival, objective tumor response<br /><br>(RECIST), duration of response, overall survival<br /><br><br /><br>Safety: Safety profile (CTC-AE, version 3.0)</p><br>

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