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Irinotecan/Cisplatin With or Without Simvastatin in Chemo-naive Patients With Extensive Disease-small Cell Lung Cancer

NCT01441349 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2022-04-06

No results posted yet for this study

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.

Conditions

  • Small Cell Lung Carcinoma

Interventions

DRUG

IP chemotherapy

Irinotecan/cisplatin (IP) chemotherapy * Cisplatin(30 mg/m2) diluted into 150 ml of 0.9% NS for IV over 30 min on day 1 \&8. * Irinotecan(65mg/m2) diluted into 200ml of 5DW IV over 90 min on day 1 \& 8 * Every 21 days

DRUG

IP chemotherapy plus simvastatin

* Cisplatin(30mg/m2)diluted into 150 ml of 0.9% NS for IV over 30 min on day 1 \&8 * Irinotecan( 65 mg/m2) diluted into 200ml of 5DW IV over 90 min on day 1\& 8. * Every 21days. * Simvastatin 40 mg per day orally D1of cycle 1

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • JI-YOUN HAN, M.D. PhD. · National Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01441349 on ClinicalTrials.gov