Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

European Organization for Research and Treatment of Cancer

Peter Reichardt

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00041236
Information obtained from ClinicalTrials.gov on December 20, 2011

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