Ecteinascidin 743 in Treating Patients With Advanced Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003939
First received: November 1, 1999
Last updated: September 20, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 132
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Detailed Description:

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
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003939

Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Axel Le Cesne, MD Gustave Roussy, Cancer Campus, Grand Paris
  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 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

Additional relevant MeSH terms:
Endometrial Neoplasms
Nervous System Neoplasms
Ovarian Neoplasms
Central Nervous System Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
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
Ileal Diseases

ClinicalTrials.gov processed this record on August 28, 2014