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

NCT01441349 | Unknown Phase 2

• 1 other identifier: NCCCTS-11-527
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Carcinoma

Keywords

Simvastatin; SCLC; Extensive Disease

Outcome Measures

Primary Outcomes (1)

• 1-year survival rate

  Survival time will be calculated from the date of study treatment start to the date of death.( or date last seen ) Follow - up visits are conducted every 8 weeks to obtain meaningful data on time- to event variables. Assessment will continue until death or 12 months after treatment.

  every 8 weeks

Secondary Outcomes (3)

• Tumor Response rate

  every 2 cycles or 6 weeks

• Progression free survival

  every 2 cycles or 6 weeks.

• Toxicity profile

  every 3 weeks

Study Arms (2)

Control arm

ACTIVE COMPARATOR

IP chemotherapy arm

Drug: IP chemotherapy

Treatment arm

EXPERIMENTAL

IP chemotherapy plus simvastatin arm

Drug: IP chemotherapy plus simvastatin

Interventions

IP chemotherapy DRUG

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

Also known as: IP

Control arm

IP chemotherapy plus simvastatin DRUG

* 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

Also known as: IPSimva

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center , Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• JI-YOUN HAN, M.D. PhD.

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, lung cancer center

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 27, 2011
• Study Start: August 1, 2011
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

KR (1)