Clinical trial · Interventional
Irinotecan/Cisplatin With or Without Simvastatin in Chemo-naive Patients With Extensive Disease-small Cell Lung Cancer
A Randomized Phase II Study of Irinotecan/Cisplatin With or Without Simvastatin in Chemo-naive Patients With Extensive Disease-small Cell Lung Cancer
NCT01441349CI-TRIAL-00057622unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IP chemotherapy | Drug | — | UNRESOLVED |
| IP chemotherapy plus simvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- IP chemotherapy arm
- interventionNames
- Drug: IP chemotherapy
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- IP chemotherapy plus simvastatin arm
- interventionNames
- Drug: IP chemotherapy plus simvastatin
Primary outcomes (1)
- measure
- 1-year survival rate
- timeFrame
- every 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.