Brostallicin or Doxorubicin as First-Line Therapy in Treating Patients With Relapsed, Refractory, or Metastatic Soft Tissue Sarcoma

NCT00410462 | Unknown Phase 2

• 3 other identifiers: EORTC-62061EUDRACT-2006-001861-40NERVIANO-BRTA-0100-015
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as brostallicin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This randomized phase II trial is studying the side effects and how well brostallicin or doxorubicin works as first-line therapy in treating patients with relapsed, refractory, or metastatic soft tissue sarcoma.

Conditions

Ovarian Cancer; Sarcoma; Small Intestine Cancer

Keywords

recurrent adult soft tissue sarcoma; stage IV adult soft tissue sarcoma; adult liposarcoma; adult fibrosarcoma; adult malignant fibrous histiocytoma; adult leiomyosarcoma; adult rhabdomyosarcoma; adult alveolar soft-part sarcoma; adult malignant mesenchymoma; adult angiosarcoma; adult epithelioid sarcoma; adult neurofibrosarcoma; adult synovial sarcoma; recurrent uterine sarcoma; stage IV uterine sarcoma; ovarian sarcoma; small intestine leiomyosarcoma; recurrent small intestine cancer

Outcome Measures

Primary Outcomes (1)

• Six-month progression-free survival, in terms of complete response, partial response, or no change

Secondary Outcomes (5)

• Overall progression-free survival

• Objective tumor response

• Safety (CTCAE v 3.0)

• Duration of response

• Overall survival

Interventions

brostallicin DRUG

doxorubicin hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed high- or intermediate-grade malignant soft tissue sarcoma\* of 1 of the following cellular types: * Adipocytic (e.g., liposarcoma dedifferentiated, myxoid/round cell, pleomorphic, mixed-type, not otherwise specified) * Fibroblastic (e.g., adult fibrosarcoma, myxofibrosarcoma, or sclerosing epithelioid fibrosarcoma) * So-called fibrohistiocytic (e.g., pleomorphic malignant fibrous histiocytoma \[MFH\], giant cell MFH, or inflammatory MFH) * Leiomyosarcoma * Malignant glomus tumors * Skeletal muscle (e.g., rhabdomyosarcoma, alveolar, or pleomorphic) * Vascular (e.g., epithelioid hemangioendothelioma or angiosarcoma) * Uncertain differentiation (e.g., synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumor \[PEComa\], or intimal sarcoma) * Malignant peripheral nerve sheath tumors * Malignant solitary fibrous tumors * Undifferentiated soft tissue sarcomas not otherwise specified * Other types of sarcoma if approved by the study coordinator NOTE: \*Includes malignant tumors of non-organ origin and skin and uterine leiomyosarcoma * The following tumor types are excluded: * Embryonal rhabdomyosarcoma * Chondrosarcoma * Osteosarcoma * Ewing tumors/primitive neuroectodermal tumor (PNET) * Gastrointestinal stromal tumors * Dermatofibrosarcoma protuberans * Inflammatory myofibroblastic sarcoma * Neuroblastoma * Malignant mesothelioma * Mixed mesodermal tumors of the uterus * Relapsed, refractory, and/or metastatic disease incurable by surgery or radiotherapy * Measurable disease * Must have formalin fixed paraffin-embedded tumor blocks and representative hematoxylin/eosin slides available for histological central review * No symptomatic or known CNS metastases PATIENT CHARACTERISTICS: * At least 60 years of age OR ≥ 18 years of age if patient is not suitable for intensive combination chemotherapy treatments * WHO performance status 0-1 * Absolute neutrophil count \> 2,000/mm³ * Platelet count \> 100,000/mm³ * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Creatinine clearance ≥ 60 mL/min * No serious cardiac illness within the past 6 months, including, but not limited to the following: * History of documented congestive heart failure * High-risk uncontrolled arrhythmias * Angina pectoris requiring antianginal medication * Clinically significant valvular heart disease * Evidence of transmural infarction on ECG * Poorly-controlled hypertension (e.g., systolic blood pressure \[BP\] \> 180 mm Hg or diastolic BP \> 100 mm Hg) * Normal 12-lead ECG * LVEF normal by MUGA or echocardiogram * No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast * No other serious and/or unstable medical condition, illness, or lab abnormality that would preclude study participation * No psychiatric illness or familial, social, or geographical condition that would preclude study compliance * No active uncontrolled infection * No known AIDS positivity * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior chemotherapy regimen for advanced or metastatic disease (neoadjuvant and adjuvant therapy allowed) * No concurrent sargramostim (GM-CSF) except in cases of febrile neutropenia * No other concurrent anticancer therapy or investigational agents, including any of the following: * Chemotherapy * Biological response modifiers * Hormone therapy * Immunotherapy * No other concurrent clinical treatment trial participation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Related Publications (1)

• Gelderblom H, Blay JY, Seddon BM, Leahy M, Ray-Coquard I, Sleijfer S, Kerst JM, Rutkowski P, Bauer S, Ouali M, Marreaud S, van der Straaten RJ, Guchelaar HJ, Weitman SD, Hogendoorn PC, Hohenberger P. Brostallicin versus doxorubicin as first-line chemotherapy in patients with advanced or metastatic soft tissue sarcoma: an European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group randomised phase II and pharmacogenetic study. Eur J Cancer. 2014 Jan;50(2):388-96. doi: 10.1016/j.ejca.2013.10.002. Epub 2013 Nov 8.

  PMID: 24215845 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Sarcoma; Liposarcoma; Fibrosarcoma; Histiocytoma, Malignant Fibrous; Leiomyosarcoma; Rhabdomyosarcoma; Sarcoma, Alveolar Soft Part; Malignant mesenchymal tumor; Hemangiosarcoma; Neurofibrosarcoma; Sarcoma, Synovial

Interventions

brostallicin; Doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Adipose Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Histiocytoma; Neoplasms, Muscle Tissue; Myosarcoma; Neoplasms, Vascular Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Hans Gelderblom, MD, PhD

  Leiden University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 13, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2008
• Last Updated: August 8, 2014

Record last verified: 2010-07

Locations

NL (1)