Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Sarcoma

Treatments: Drug: exatecan mesylate

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00041236

EORTC-62006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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