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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Samsung Medical Center | OTHER |
| Seoul National University Hospital | OTHER |
| Ulsan University Hospital |
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A phase II study is conducted to determine the efficacy and safety of a single agent Camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small cell lung cancer patients previously treated with chemotherapy. The usefulness of the this regimen is evaluated by response rate, median survival time, progression free survival and duration of response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belotecan | Experimental | Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belotecan | Drug | 3.0 mg/m2, Day 1, 8, 15 every 4 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | every 2 cyc |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 6 months after Last patient out | |
| Progression Free survival | 6 months after Last patient out | |
| Adverse event |
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Inclusion Criteria:
19 Years and older
Histologically or cytologically confirmed locally advanced or metastatic NSCLC(Stage IIIB or IV)
≥ one measureable or evaluable lesion, <25% of the bone marrow had been irradiated
prior platinum based chemotherapy
ECOG PS ≤ 2
Life expectancy > 3 months
Adequate organ function:
Signed a written informed consent
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C116963 | belotecan |
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| OTHER |
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| every visit |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |