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| ID | Type | Description | Link |
|---|---|---|---|
| YONSEI-4-2008-0127 | |||
| CKDPC-YONSEI-4-2008-0127 | |||
| YONSEI-07-YUHS-02 |
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RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving belotecan together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive cisplatin IV on day 1 and belotecan hydrochloride IV on days 2-4.Treatment continues in the absence of disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| belotecan and Cisplatin | Experimental | belotecan 0.5 mg/m2 and Cisplatin 60mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| belotecan hydrochloride | Drug |
| ||
| cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate as assessed by RECIST criteria | 21days(1cycle) | |
| Overall survival | 21days(1cycle) | |
| Progression-free survival | 21days(1cycle) | |
| Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0 | 21days(1cycle) |
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DISEASE CHARACTERISTICS:
Histologically confirmed small cell lung cancer meeting the following criteria:
At least one measurable disease
No brain or leptomeningeal metastasis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Joo-Hang Kim, MD | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cancer Center at Yonsei University Medical Center | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C116963 | belotecan |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |