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Sponsors and Collaborators: |
Daiichi Sankyo Inc. National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00064220 |
RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: soblidotin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, to Patients With Advanced or Metastatic Soft Tissue Sarcomas (STS) With Prior Exposure to Anthracycline-Based Chemotherapy |
Study Start Date: | April 2003 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 12 months.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue sarcoma of 1 of the following tumor types:
The following tumor types are not eligible:
Must have received 1 prior anthracycline-based chemotherapy regimen for metastatic disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent radiotherapy
Surgery
Other
United States, Alabama | |
University of Alabama at Birmingham Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294-3300 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
Puerto Rico | |
Veterans Affairs Medical Center - San Juan | |
San Juan, Puerto Rico, 00927-5800 |
Study Chair: | Juan Pagan | Daiichi Sankyo Inc. |
Study ID Numbers: | CDR0000310138, DAIICHI-1027A-PRT007, CPMC-IRB-20030512, MSKCC-03061 |
Study First Received: | July 8, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00064220 |
Health Authority: | United States: Federal Government |
adult leiomyosarcoma adult malignant fibrous histiocytoma adult liposarcoma adult rhabdomyosarcoma adult synovial sarcoma |
adult fibrosarcoma adult angiosarcoma adult malignant hemangiopericytoma stage IV adult soft tissue sarcoma recurrent adult soft tissue sarcoma |
Histiocytoma, Malignant Fibrous Fibrosarcoma Leiomyosarcoma Histiocytoma, Benign Fibrous Synovial sarcoma Malignant mesenchymal tumor Hemangiosarcoma Hemangiopericytoma Soblidotin |
Soft tissue sarcomas Recurrence Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Liposarcoma Histiocytoma Sarcoma Malignant fibrous histiocytoma Rhabdomyosarcoma |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |