- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00452634
Irinotecan/Cisplatin Plus Simvastatin in Extensive Disease-Small Cell Lung Cancer (ED-SCLC)
June 17, 2013 updated by: Ji-youn Han, National Cancer Center, Korea
A Phase II Study of Irinotecan/Cisplatin Plus Simvastatin in Chemo-naive Patients With Extensive Disease-Small Cell Lung Cancer
3-Hydroxy-3-methylglutaryl CoA reductase inhibitors, commonly referred to as the statins, have proven therapeutic and preventative effects in cardiovascular diseases.
Recently, there are emerging interests in their use as anticancer agents based on preclinical evidence of their antiproliferative, proapoptotic, anti-invasive, and radiosensitizing properties.
Inhibition of 3-hydroxy-3-methylglutaryl CoA reductase by the statins interferes with the rate-limiting step of the mevalonate pathway, leading to reduced levels of mevalonate and its downstream products, many of which play important roles in critical cellular functions such as membrane integrity, cell signaling, protein synthesis, and cell cycle progression.
Perturbations of these processes in neoplastic cells by the statins may therefore result in control of tumor initiation, growth, and metastasis.
The statins have demonstrated growth inhibitory activity in cancer cell lines and preclinical tumor models in animals.
Simvastatin, a member of the statin family, profoundly impaired basal and growth factor-stimulated SCLC cell growth in vitro and induced apoptosis.
SCLC cells treated with simvastatin were sensitized to the effects of the chemotherapeutic agent etoposide.
Moreover, SCLC tumour growth in vivo was inhibited by simvastatin.
Therefore, the investigators will conduct this phase II trial to evaluate the efficacy & toxicity of irinotecan/cisplatin plus simvastatin in patients with chemo-naïve ED-SCLC.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cisplatin-30 mg/m2 on day 1 and 8 repeat q 3 weeks Irinotecan-65 mg/m2 on day1 and 8 repeat q 3 weeks Simvastatin 40 mg per day orally from D1 of cycle 1
Treatment will be continued until disease progression, unacceptable toxicity, or patients' refusal.
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyenggi
-
Goyang-si, Gyenggi, Korea, Republic of, 411-769
- National Cancer Center, Korea
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologic or cytologic diagnosis of SCLC
- Extensive-stage disease, defined as disease extending beyond one hemithorax or involving contralateral mediastinal, hilar or supraclavicular lymph nodes, and/or pleural effusion.
- No prior chemotherapy, immunotherapy, or radiotherapy
- Performance status of 0, 1, 2 on the ECOG criteria.
- At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
- Patient compliance that allow adequate follow-up.
- Adequate hematologic (WBC count ≥ 4,000/mm3, platelet count ≥ 150,000/mm3), hepatic (bilirubin level ≤ 1.5 mg/dL, AST/ALT ≤ 80 IU/L), and renal (creatinine concentration ≤ 1.5 mg/dL) function.
- Informed consent from patient or patient's relative.
- Males or 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 [IUD], birth control pills, or barrier device) during and 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 within 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study arm
|
Irinotecan 65mg/m2/iv over 90min on day 1 and 8, repeat Q 3weeks.
until disease progression, unacceptable toxicity or patients' refusal.
Cisplatin 30mg/m2/iv over 30min on day 1 and 8, repeat Q 3weeks.
until disease progression, unacceptable toxicity or patients' refusal.
simvastatin 40mg/QD, PO, daily, every 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1-year survival & overall survival
Time Frame: the first day of treatment to death or last survival confirm date
|
the first day of treatment to death or last survival confirm date
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor response rate
Time Frame: the ratio between the number of responders and number of patients assessable for tumor response
|
the ratio between the number of responders and number of patients assessable for tumor response
|
Time to progression
Time Frame: the first day of treatment to the date that disease progression is reported
|
the first day of treatment to the date that disease progression is reported
|
Toxicity
Time Frame: the first date of treatment to 30 days after the last dose of study drug
|
the first date of treatment to 30 days after the last dose of study drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ji-Youn Han, M.D.,Ph.D., National Cancer Center, Korea
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
March 26, 2007
First Submitted That Met QC Criteria
March 26, 2007
First Posted (Estimate)
March 27, 2007
Study Record Updates
Last Update Posted (Estimate)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 17, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Topoisomerase I Inhibitors
- Cisplatin
- Irinotecan
- Simvastatin
Other Study ID Numbers
- NCCCTS-06-176
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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