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Phase II Study on ET-743 in Advanced Soft Tissue Sarcomas of the Adult

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors, Endometrial Cancer, Gastrointestinal Stromal Tumor, Ovarian Cancer, Sarcoma, Small Intestine Cancer

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Trial Information

Phase II Study on ET-743 in Advanced Soft Tissue Sarcomas of the Adult

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

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.

Inclusion 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

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not
specified Hematopoietic: Neutrophil count at least 2,000/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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Axel Le Cesne, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Endometrial Cancer
  • Gastrointestinal Stromal Tumor
  • Ovarian Cancer
  • Sarcoma
  • Small Intestine Cancer
  • adult angiosarcoma
  • adult fibrosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • adult neurofibrosarcoma
  • adult synovial sarcoma
  • stage IV adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • small intestine leiomyosarcoma
  • adult alveolar soft-part sarcoma
  • adult epithelioid sarcoma
  • adult malignant fibrous histiocytoma
  • adult malignant hemangiopericytoma
  • adult malignant mesenchymoma
  • adult rhabdomyosarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • uterine carcinosarcoma
  • uterine leiomyosarcoma
  • endometrial stromal sarcoma
  • ovarian sarcoma
  • adult meningeal hemangiopericytoma
  • gastrointestinal stromal tumor
  • Endometrial Neoplasms
  • Nervous System Neoplasms
  • Ovarian Neoplasms
  • Central Nervous System Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Adenoma
  • Gastrointestinal Stromal Tumors
  • Intestinal Neoplasms
  • Sarcoma