Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

NCT00041236 | Completed Phase 2

• 1 other identifier: EORTC-62006
• Study Type: interventional
• Target: 39
• Locations: 4 countries
• Sites: 10

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.

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

Interventions

exatecan mesylate DRUG

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue sarcoma * Malignant fibrous histiocytoma * Liposarcoma * Rhabdomyosarcoma * Synovial sarcoma * Malignant paraganglioma * Fibrosarcoma * Leiomyosarcoma * Angiosarcoma including hemangiopericytoma * Malignant peripheral nerve sheath tumor * Unclassified sarcoma * Miscellaneous sarcoma including mixed mesodermal tumors of the uterus * The following tumor types are excluded: * 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

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 (10)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

Aarhus, DK-8000, Denmark

Location

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

Berlin, D-13122, Germany

Location

Universitatsklinikum Carl Gustav Carl Carus

Dresden, D-01307, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Universitaets-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Eberhard Karls Universitaet

Tübingen, D-72076, Germany

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Related Publications (2)

• 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.

  PMID: 17336054 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Sarcoma; Hemangiosarcoma; Fibrosarcoma; Leiomyosarcoma; Liposarcoma; Neurofibrosarcoma; Sarcoma, Synovial; Histiocytoma, Malignant Fibrous; Hemangiopericytoma, Malignant; Rhabdomyosarcoma

Interventions

exatecan

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Histiocytoma; Myosarcoma

Study Officials

• Peter Reichardt, MD

  Robert Roessle Klinik

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: December 1, 2004
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

DK (1); SL (1); BE (2); DE (6)