Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma
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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 | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Endometrial Cancer Gastrointestinal Stromal Tumor Ovarian Cancer Sarcoma Small Intestine Cancer |
Drug: trabectedin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study on ET-743 in Advanced Soft Tissue Sarcomas of the Adult |
| Enrollment: | 132 |
| Primary Completion Date: | November 2000 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00003939 History of Changes |
| Other Study ID Numbers: | EORTC-62982-16993, EORTC-62982 |
| Study First Received: | November 1, 1999 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
adult alveolar soft-part sarcoma 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 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 |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Nervous System Neoplasms Ovarian Neoplasms Central Nervous System Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Adenoma Gastrointestinal Stromal Tumors Intestinal Neoplasms Sarcoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Diseases Genital Diseases, Female Nervous System Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013