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| ID | Type | Description | Link |
|---|---|---|---|
| DAIICHI-1027A-PRT007 | |||
| CPMC-IRB-20030512 | |||
| MSKCC-03061 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soblidotin | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue sarcoma of 1 of the following tumor types:
The following tumor types are not eligible:
Evidence of disease progression
Must have received 1 prior anthracycline-based chemotherapy regimen for metastatic disease
At least 1 measurable lesion with indicator lesions outside of any prior radiation field
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
See Disease Characteristics
Recovered from prior radiotherapy
No concurrent radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Juan Pagan | Daiichi Sankyo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17109446 | Result | Patel S, Keohan ML, Saif MW, Rushing D, Baez L, Feit K, DeJager R, Anderson S. Phase II study of intravenous TZT-1027 in patients with advanced or metastatic soft-tissue sarcomas with prior exposure to anthracycline-based chemotherapy. Cancer. 2006 Dec 15;107(12):2881-7. doi: 10.1002/cncr.22334. |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D007890 | Leiomyosarcoma |
| D051677 | Histiocytoma, Malignant Fibrous |
| D008080 | Liposarcoma |
| D012208 | Rhabdomyosarcoma |
| D013584 | Sarcoma, Synovial |
| D005354 | Fibrosarcoma |
| D006394 | Hemangiosarcoma |
| C562740 | Hemangiopericytoma, Malignant |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009379 | Neoplasms, Muscle Tissue |
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| ID | Term |
|---|---|
| C105791 | soblidotin |
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| Indiana University Cancer Center |
| Indianapolis |
| Indiana |
| 46202-5289 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | 10032 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Veterans Affairs Medical Center - San Juan | San Juan | 00927-5800 | Puerto Rico |
| D051642 | Histiocytoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018205 | Neoplasms, Adipose Tissue |
| D009217 | Myosarcoma |
| D009383 | Neoplasms, Vascular Tissue |