Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00041249
First received: July 8, 2002
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Sarcoma
Drug: brostallicin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 64
Study Start Date: May 2002
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of brostallicin, in terms of objective response, in patients with locally advanced or metastatic soft tissue sarcoma who have failed one prior chemotherapy treatment.
  • Determine the time to progression and duration of response in patients treated with this drug.
  • Determine the safety and toxic effects of this drug in these patients.
  • Correlate clinical outcome with whole blood glutathione level in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor (tumors other than gastrointestinal stromal tumor (GIST) vs GIST).

Patients receive brostallicin IV over 10 minutes on day 1. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year and then every 4 months for 1 year.

PROJECTED ACCRUAL: A total of 58-72 patients (40 for stratum I and 18-32 for stratum II) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed soft tissue sarcoma that is not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
  • Stratum I

    • Malignant fibrous histiocytoma
    • Liposarcoma
    • Rhabdomyosarcoma
    • Synovial sarcoma
    • Malignant paraganglioma
    • Fibrosarcoma
    • Leiomyosarcoma
    • Angiosarcoma including hemangiopericytoma
    • Malignant peripheral nerve sheath tumor
    • Unclassified sarcoma
    • Miscellaneous sarcoma
  • Stratum II

    • Gastrointestinal stromal tumor
    • Previously treated with imatinib mesylate for locally advanced or metastatic disease and demonstrated disease progression
  • The following sarcoma types are excluded:

    • Mixed mesodermal tumors of the uterus (and carcinosarcoma)
    • Chondrosarcoma
    • Malignant mesothelioma
    • Neuroblastoma
    • Osteosarcoma
    • Ewing's sarcoma
    • Embryonal rhabdomyosarcoma
  • At least one measurable lesion
  • Progressive disease after 1 prior anthracycline- and/or alkylating-containing chemotherapy regimen for locally advanced or metastatic disease
  • Clinical evidence of progression within 6 weeks prior to study treatment
  • No known or symptomatic CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • Over 15

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • SGPT and SGOT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.4 mg/dL OR
  • Creatinine clearance greater than 65 mL/min

Cardiovascular:

  • No prior severe cardiovascular disease

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 6 months after study
  • No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  • No other severe medical illness
  • No psychosis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic response modifiers or immunotherapy
  • No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim (G- CSF) or sargramostim (GM-CSF)

Chemotherapy:

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy and recovered
  • Prior adjuvant chemotherapy as first-line treatment allowed provided disease progressed within 6 months after the completion of chemotherapy
  • No prior ecteinascidin 743 (stratum I)
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No prior radiotherapy to sole measurable lesion
  • Concurrent palliative radiotherapy to nontarget lesions allowed at investigator's discretion

Surgery:

  • See Disease Characteristics
  • Recovered from prior surgery

Other:

  • No other concurrent anticancer therapy (approved or investigational)
  • No concurrent participation in any other clinical treatment study
  • No other concurrent investigational drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041249

Locations
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
France
Centre Leon Berard
Lyon, France, 69008
CHU de la Timone
Marseille, France, 13385
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Robert Roessle Klinik
Berlin, Germany, D-13122
Universitaets-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
Munich, Germany, D-81377
Netherlands
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9700 RB
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
Rotterdam, Netherlands, 3008 AE
United Kingdom
St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Royal Marsden NHS Trust - London
London, England, United Kingdom, SW3 6JJ
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Michael Leahy, MBChB, FRACP, FRCP, FRC Path Fremantle Hospital
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00041249     History of Changes
Other Study ID Numbers: EORTC-62011, EORTC-62011
Study First Received: July 8, 2002
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult angiosarcoma
adult fibrosarcoma
adult leiomyosarcoma
adult liposarcoma
adult neurofibrosarcoma
adult synovial sarcoma
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
adult malignant fibrous histiocytoma
adult malignant hemangiopericytoma
adult rhabdomyosarcoma
gastrointestinal stromal tumor
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Sarcoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 29, 2014