Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

NCT ID: NCT00041236

Last Updated: 2012-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31

Brief 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 exatecan mesylate in treating patients who have advanced soft tissue sarcoma.

Detailed Description

OBJECTIVES:

• Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma.
• Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies).

Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival.

PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.

Conditions

Sarcoma

Keywords

adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult neurofibrosarcoma; adult synovial sarcoma; stage IV adult soft tissue sarcoma; recurrent adult soft tissue sarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; adult rhabdomyosarcoma; stage IV uterine sarcoma; recurrent uterine sarcoma; uterine leiomyosarcoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

exatecan mesylate

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Gastrointestinal stromal tumor
• Chondrosarcoma
• Malignant mesothelioma
• Neuroblastoma
• Osteosarcoma
• Ewing's sarcoma
• Embryonal rhabdomyosarcoma
• Prior chemotherapy for metastatic disease required

• One line of combination chemotherapy containing anthracycline OR
• No more than 2 single-agent regimens including anthracycline
• Adjuvant chemotherapy not considered first line unless tumor progresses within 6 months after treatment
• Must have 1 measurable lesion

• Clinical evidence of progression within 6 weeks prior to study
• Osseous lesions and pleural effusions not considered measurable
• No known or symptomatic CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 15 to 75

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 1.8 mg/dL
• Albumin at least 2.5 g/dL

Renal:

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

Cardiovascular:

• No history of severe cardiovascular disease

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy
• No other concurrent cytotoxic therapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No radiotherapy to the sole measurable lesion
• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No other investigational drugs for 28 days prior to, during, and for 28 days after completion of study drug
• No other concurrent anticancer therapy

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Reichardt, MD

Role: STUDY_CHAIR

Robert Roessle Klinik

Locations

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

U.Z. Gasthuisberg

Leuven, , Belgium

Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

Aarhus, , Denmark

Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

Berlin, , Germany

Universitatsklinikum Carl Gustav Carl Carus

Dresden, , Germany

Universitaetsklinikum Essen

Essen, , Germany

Universitaets-Krankenhaus Eppendorf

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Eberhard Karls Universitaet

Tübingen, , Germany

National Cancer Institute - Bratislava

Bratislava, , Slovakia

Countries

Belgium; Denmark; Germany; Slovakia

References

Reichardt P, Nielsen OS, Bauer S, Hartmann JT, Schoffski P, Christensen TB, Pink D, Daugaard S, Marreaud S, Van Glabbeke M, Blay JY; EORTC Soft Tissue and Bone Sarcoma Group. Exatecan in pretreated adult patients with advanced soft tissue sarcoma: results of a phase II--study of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2007 Apr;43(6):1017-22. doi: 10.1016/j.ejca.2007.01.014. Epub 2007 Mar 1.

Reference Type: RESULT

PMID: 17336054 (View on PubMed)

Pink D, Reichardt P, Nielsen OS, et al.: Exatecan (DX-8951f), a new topoisomerase I - inhibitor, is inactive in heavily pretreated patients (pts.) with advanced soft tissue sarcoma (STS): a phase II study of the EORTC Soft Tissue and Bone Sarcoma Group. [Abstract] J Clin Oncol 23 (Suppl 16): A-9058, 830s, 2005.

Reference Type: RESULT

Other Identifiers

EORTC-62006

Identifier Type: -

Identifier Source: secondary_id

EORTC-62006

Identifier Type: -

Identifier Source: org_study_id