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The purpose of this study is to identify the appropriate dose of irinotecan by dose escalation(dose climbing) test. The study would provide rationale for regimen decision in a future phase III clinical trial, in which irinotecan combined with cisplatin(IP) will be selected as therapeutic drugs.
To determine the Maximum Tolerated Dose (MTD) and Limiting Toxicity (DLTs) of irinotecan in patients with extensive stage small cell lung cancer treated with irinotecan plus cisplatin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| irinotecan | Experimental | irinotecan; 60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irinotecan | Drug | 60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Limiting Toxicity (DLT )in the irinotecan | up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose(MTD)in the irinotecan | up to 18weeks |
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Inclusion Criteria:
Age 18 to 65 years, male and female
Histologically or cytologically confirmed extensive stage .small cell lung cancer(SCLC )(except metastases only as pleural effusion)
No prior chemotherapy
Metastatic lesion had been treated more than 14 days by palliative radiation therapy or surgery
With measurable tumor lesions (Non-irradiated parts),(RECIST 1.1: Without radiotherapy ,the longest diameter is more than 10mm by CT or MRI ,except that lymph nodes need short diameter need more then 15mm, and the lesions can be accurately evaluated repeatedly measurable)
Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
Expected survival ≥ 3months
Marrow,kidney, liver,heart and lung are well -functioning,and absolute count of
No pregnancy or no pregnancy demand at the end of the study within six months
Must provide written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ying cheng, doctor | Contact | 86-43185871902 | jl.cheng@163.com | |
| qian liu, bachelor | Contact | 86-43185873196 | xjy0202@163.com |
| Name | Affiliation | Role |
|---|---|---|
| ying cheng, doctor | Jilin Provincial Tumor Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jilin cancer hospital | Recruiting | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |