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| ID | Type | Description | Link |
|---|---|---|---|
| DAIICHI-1027A-PRT005 | |||
| MSKCC-03016 |
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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 progressive locally advanced or metastatic non-small cell lung cancer.
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive soblidotin IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Plasma sampling for pharmacokinetics is done on day 1 of course 1.
Patients are followed for survival every 3 months after discontinuing study treatment.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 1 year.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soblidotin | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Demonstrates tumor progression
Must have received 1 prior chemotherapy regimen
Measurable disease
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiac
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
See Disease Characteristics
Recovered from prior radiotherapy
No concurrent anticancer radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Peter Cheverton, MD, ChB, MMED, RadT | Daiichi Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Oncology and Hematology, P.C. | Waterbury | Connecticut | 06708 | United States | ||
| Barbara Ann Karmanos Cancer Institute |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C105791 | soblidotin |
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| Detroit |
| Michigan |
| 48201-1379 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |