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

August 7, 2014 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Randomized Phase II Study of Brostallicin (PNU-166196A) Versus Doxorubicin as First Line Chemotherapy in Patients With Advanced or Metastatic Soft Tissue Sarcoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the activity and safety of brostallicin vs doxorubicin hydrochloride as first-line therapy in patients with relapsed, refractory, or metastatic soft tissue sarcoma.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating and age(younger than 60 years vs 60 years and over). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive brostallicin IV over 10 minutes on day 1.
  • Arm II: Patients receive doxorubicin hydrochloride IV over 10 minutes on day 1. In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 108 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2300 RC
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Overall survival
Duration of response
Objective tumor response
Overall progression-free survival
Safety (CTCAE v 3.0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Hans Gelderblom, MD, PhD, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 11, 2006

First Submitted That Met QC Criteria

December 11, 2006

First Posted (Estimate)

December 13, 2006

Study Record Updates

Last Update Posted (Estimate)

August 8, 2014

Last Update Submitted That Met QC Criteria

August 7, 2014

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-62061
  • EUDRACT-2006-001861-40
  • NERVIANO-BRTA-0100-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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