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.

Condition	Treatment or Intervention	Phase
adult soft tissue sarcoma uterine leiomyosarcoma uterine sarcoma	Drug: exatecan mesylate  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  15 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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

Belgium
      Cliniques Universitaires Saint-Luc, Brussels,  1200,  Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
Denmark
      Aarhus University Hospital - Aarhus Sygehus - Norrebrogade, Aarhus,  DK-8000,  Denmark
Germany
      Eberhard Karls Universitaet, Tuebingen,  D-72076,  Germany
      Medizinische Hochschule Hannover, Hannover,  D-30625,  Germany
      Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch, Berlin,  D-13122,  Germany
      Universitaetsklinikum Essen, ESSEN,  D-45122,  Germany
      Universitaets-Krankenhaus Eppendorf, Hamburg,  D-20246,  Germany
      Universitatsklinikum Carl Gustav Carl Carus, Dresden,  D-01307,  Germany
Slovakia
      National Cancer Institute - Bratislava, Bratislava,  833 10,  Slovakia

Study chairs or principal investigators

Peter Reichardt, MD,  Robert Roessle Klinik   

Study ID Numbers:  CDR0000069455; EORTC-62006; NCT00041236
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00041236
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08