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Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma - Article


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Sarcoma, Kaposi's


Clinical Trial: Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma

This study is no longer recruiting patients.

Sponsored by: EORTC Soft Tissue and Bone Sarcoma Cooperative Group
Information provided by: National Cancer Institute (NCI)

Purpose

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 ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma.

Condition Treatment or Intervention Phase
adult soft tissue sarcoma
ovarian sarcoma
Brain Tumor
uterine sarcoma
 Drug: ecteinascidin 743
Phase II

MedlinePlus related topics:  Brain Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Ecteinascidin 743 in Patients with Advanced Soft Tissue Sarcomas

Further Study Details: 

OBJECTIVES: I. Assess the therapeutic activity of ecteinascidin 743 in patients with advanced soft tissue sarcomas. II. Assess the duration of response in these patients. III. Determine the acute side effects in these patients.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive ecteinascidin 743 (ET-743) IV over 24 hours every 3 weeks. Treatment continues for at least 2-6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and every 12 weeks after disease progression.

PROJECTED ACCRUAL: Approximately 28-44 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically proven soft tissue sarcoma, including the following cell types: Malignant fibrous histiocytoma; Liposarcoma; Rhabdomyosarcoma; Synovial sarcoma; Malignant paraganglioma; Fibrosarcoma; Leiomyosarcoma; Angiosarcoma including hemangiopericytoma; Neurogenic sarcoma; Unclassified sarcoma; Miscellaneous sarcoma including mixed mesodermal tumors of the uterus
  • Cell types NOT allowed: Malignant mesothelioma; Chondrosarcoma; Neuroblastoma Osteosarcoma; Ewing's sarcoma; Embryonal rhabdomyosarcoma
  • Measurable lesion with evidence of progression within 6 weeks prior to study (osseous lesions, hepatomegaly, lymphedema, ascites, and pleural lesions are not considered measurable)
  • No symptomatic or known CNS metastases

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: At least 4 weeks since prior chemotherapy; No more than 1 prior regimen of combination chemotherapy OR No more than 2 prior single agent regimens; No other concurrent chemotherapy
  • Endocrine therapy: Not specified
  • Radiotherapy: No prior radiotherapy to sole index lesion; No concurrent radiotherapy
  • Surgery: Not specified
  • Other: No other concurrent investigational drugs

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: WHO 0 or 1
  • Life expectancy: Not specified
  • Hematopoietic: Neutrophil count at least 2000/mm3; Platelet count at least 100,000/mm3
  • Hepatic: Bilirubin no greater than 1.75 mg/dL; Albumin at least 2.5 g/dL; AST and ALT less than 1.5 times upper limit of normal (ULN) (2.5 times ULN if liver metastasis present); Alkaline phosphatase less than 2.5 times ULN; No other significant hepatic disease (e.g., active hepatitis, cirrhosis, etc.)
  • Renal: Creatinine no greater than 1.36 mg/dL OR Creatinine clearance at least 60 mL/min
  • Cardiovascular: No prior cardiovascular disease
  • Other: No other severe medical illness; No psychosis; No prior or concurrent second primary malignant tumors, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma; Fertile patients must use effective contraception

Location Information

Study chairs or principal investigators

Ole Steen Nielsen,  Study Chair,  EORTC Soft Tissue and Bone Sarcoma Cooperative Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067132; EORTC-62982
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003939
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 8, 2008



Page Updated: September 23, 2004
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