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

Sarcoma Clinical Trial

Official title:

Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041249
• Other study ID #: EORTC-62011
• Secondary ID: EORTC-62011
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2002
• Last updated: July 17, 2012
• Start date: May 2002

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Sarcoma

Intervention

Drug:
• brostallicin

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
France	Centre Leon Berard	Lyon
France	CHU de la Timone	Marseille
France	Institut Gustave Roussy	Villejuif
Germany	Robert Roessle Klinik	Berlin
Germany	Universitaets-Krankenhaus Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen	Munich
Netherlands	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Daniel Den Hoed Cancer Center at Erasmus University Medical Center	Rotterdam
United Kingdom	St. James's University Hospital	Leeds	England
United Kingdom	Royal Marsden NHS Trust - London	London	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle Upon Tyne	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands,  United Kingdom, 

References & Publications (2)

Leahy M, Ray-Coquard I, Verweij J, Le Cesne A, Duffaud F, Hogendoorn PC, Fowst C, de Balincourt C, di Paola ED, van Glabbeke M, Judson I, Blay JY; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Brostallicin, — View Citation

Leahy MG, Blay JY, Verweij J, et al.: EORTC 62011: phase II trial of brostallicin for soft tissue sarcoma. [Abstract] Eur J Cancer Suppl 1 (5): S209, A-694, 2003.