Status:
UNKNOWN
Irinotecan/Cisplatin With or Without Simvastatin in Chemo-naive Patients With Extensive Disease-small Cell Lung Cancer
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the efficacy of Simvastatin and Irinotecan/Cisplatin chemotherapy with Irinotecan/Cisplatin chemotherapy alone in Extensive disease-small cell lung cancer.
Detailed Description
Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) have been used to treat hypercholesterolemia. Besides the lipid lowering effects, they also act as anti-inflammatory and anti-cance...
Eligibility Criteria
Inclusion
- Histologically confirmed SCLC
- Extensive - stage disease, defined as disease extending beyond one hemithorax or involving contralateral mediastinal, hilar or supraclavicular lymph nodes, and/ or pleural effusion
- ever smoker( have smoked\> 100 cigarettes in entire lifetime
- No prior chemotherapy, immunotherapy, or radiotherapy
- Measurable disease according to RECIST 1.1
- Patient compliance that allow adequate follow - up
- Adequate hematologic , hepatic and renal function.
- Written informed consent that is consistent with International Conference on Harmonization (ICH) - Good Clinical Practice (GCP) guidelines
- Males of females at least 18 years of age
- If female : childbearing potential either terminated by surgery, radiation, or menopause or attenuated by use of an approved contraceptive method(intrauterine device, birth control pills, or barrier device)during for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study enrollment.
- No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole.
- Patients with brain metastasis are allowed unless there were clinically significant neurological symptoms or signs.
Exclusion
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- A serious cardiac condition, such as myocardial infarction with 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Concurrent administration of any other antitumor therapy.
- Pregnant or Breast-feeding.
- Taking simvastatin or Any contraindications for therapy with simvastatin
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT01441349
Start Date
August 1 2011
End Date
December 31 2022
Last Update
April 6 2022
Active Locations (1)
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1
National Cancer Center , Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769