Study of Different Doses of Irinotecan and Cisplatin for First-line Extensive-stage Small-cell Lung Cancer Treatment
NCT ID: NCT02171325
Last Updated: 2021-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
54 participants
INTERVENTIONAL
2014-06-30
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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irinotecan
irinotecan； 60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2
irinotecan
60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2
Interventions
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irinotecan
60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2
Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed extensive stage .small cell lung cancer(SCLC )（except metastases only as pleural effusion）
3. No prior chemotherapy
4. Metastatic lesion had been treated more than 14 days by palliative radiation therapy or surgery
5. 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)
6. Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
7. Expected survival ≥ 3months
8. Marrow,kidney, liver,heart and lung are well -functioning,and absolute count of
* absolute neutrophil coun(ANC) ≥ 2.0 × 109 / L
* blood platelet(PLT) ≥ 100 × 109 / L
* Hb≥ 90g / L
* conjugative bilirubin(CB)≤ upper limit of normal(ULN) × 1.5
* Aspartate transaminase(AST )(glutamic oxalacetic transaminase,GOT): ≤ upper limit of normal(ULN )× 2.5
* Alanine aminotransferase(ALT)(Glutamate Pyruvate Transaminase,GPT): ≤ ULN × 2.5
* Serum creatinine: ≤ ULN or calculated creatinine clearance≥ 60 ml / min
* (PT INR) ≤ ULN × 1.5
* ECG: no abnormalities in need of treatment
9. No pregnancy or no pregnancy demand at the end of the study within six months
10. Must provide written informed consent.
Exclusion Criteria
2. Patient with active ulcer disease or chronic enteritis patients
3. Primary lesion(s) has (have) been treated by Surgery or radiation
4. Patient had received Immune drugs treatment for anti-lung cancer indications or anti-cancer Chinese traditional medicine treatment within two weeks
5. Patients with interstitial pneumonia or pulmonary fibrosis
6. Brain metastasis requiring treatment
7. Patient with bronchus or bronchial stenosis or blockage and superior vena cava syndrome caused by serious invasion
8. Patients with severe infections, severe abnormal secretion of (Anti Diuretic Hormone,ADH) syndrome, poorly controlled diabetes, severe complications requiring treatment vena cava syndrome
9. Severe cardiovascular disease: hypertension that medical treatment can not be controlled , unstable angina, myocardial infarction within the last June a history of congestive heart failure\> 3 (NYHA) and severe arrhythmia
18 Years
65 Years
ALL
No
Sponsors
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Guangdong Association of Clinical Trials
OTHER
Responsible Party
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Principal Investigators
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ying cheng, doctor
Role: PRINCIPAL_INVESTIGATOR
Jilin Provincial Tumor Hospital
Locations
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Jilin cancer hospital
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTONG1402
Identifier Type: -
Identifier Source: org_study_id
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