Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: exatecan mesylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: exatecan mesylate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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