Overview

Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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 ecteinascidin 743 in treating patients who have advanced soft tissue sarcoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Treatments:
Trabectedin
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 drugs