Combined Simvastatin and Irinotecan in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy
Clinical Study of Irinotecan With or Without Simvastatin in Treating Extensive-Stage Small Cell Lung Cancer Patients Relapsed From First-line Chemotherapy
1 other identifier
interventional
40
1 country
2
Brief Summary
This Phase II study was designed to evaluate the safety and efficacy of irinotecan in combination with simvastatin compared with treatment with irinotecan alone in ES-SCLC patients relapsed from first-line chemotherapy. Participants will be divided in a 1:1 ratio to receive either irinotecan (4 cycles) + simvastatin (10 months) or irinotecan (4 cycles) until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 2, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedAugust 9, 2021
August 1, 2021
1.1 years
July 26, 2021
August 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
To evaluate the progression-free survival (PFS) of patients.
12 weeks
Secondary Outcomes (4)
Disease control rate (DCR)
6 weeks
Overall response rate (ORR)
6 weeks
Overall survival (OS)
24 weeks
Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v4.0
24 weeks
Study Arms (2)
Simvastatin + Irinotecan
EXPERIMENTALreceived intravenous infusions of Irinotecan 60 milligrams per square meter (mg/m\^2) on Day 1,8 of every 21-day cycle (4 cycles) in combination with oral simvastatin (20mg daily) (10 months)
Irinotecan
ACTIVE COMPARATORreceived intravenous infusions of Irinotecan 60 milligrams per square meter (mg/m\^2) on Day 1,8 of every 21-day cycle (4 cycles)
Interventions
Irinotecan intravenous infusion was administered at a dose of 60 mg/m\^2 on Day 1,8 of each 21-day cycle.
Simvastatin 40 mg daily oral tablet taken.
Eligibility Criteria
You may qualify if:
- Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and be able to complete all test procedures.
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system).
- No patients with resectable or radical radiotherapy lung cancer. Patient must have no Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) rearrangement, or ROS proto-oncogene 1 , receptor tyrosine kinase(ROS1) rearrangement.
- Patient must be at least resistant to the first-line chemotherapy. Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Patients can tolerate chemotherapy.
You may not qualify if:
- Unclear diagnosis of SCLC. Resectable or radical radiotherapy SCLC. Contraindicated chemotherapy. Undergoing other active malignancies within 5 years or at the same time.Patients with localized curable tumors, such as basal cell carcinoma, squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ, will not be excluded.
- Positive test result for human immunodeficiency virus (HIV). Positive test result for active tuberculosis. Live vaccine was administered within 28 days of initial administration. Inactivated viral vaccines for seasonal influenza are allowed, except for live attenuated intranasal vaccines.
- Pregnant or lactating women. A history of psychotropic substance abuse, drug abuse, or alcoholism. Other factors assessed by the sponsors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CAS Center for Excellence in Molecular Cell Science, Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, 200031, China
Shanghai pulmonary hospital, Tongji University
Shanghai, Shanghai Municipality, 200433, China
Related Publications (5)
Goldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Thiyagarajah P, Jiang H, Paz-Ares L; CASPIAN investigators. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8. Epub 2020 Dec 4.
PMID: 33285097RESULTGelsomino F, Tiseo M, Barbieri F, Riccardi F, Cavanna L, Frassoldati A, Delmonte A, Longo L, Dazzi C, Cinieri S, Colantonio I, Sperandi F, Lamberti G, Brocchi S, Tofani L, Boni L, Ardizzoni A. Phase 2 study of NAB-paclitaxel in SensiTivE and refractory relapsed small cell lung cancer (SCLC) (NABSTER TRIAL). Br J Cancer. 2020 Jul;123(1):26-32. doi: 10.1038/s41416-020-0845-3. Epub 2020 Apr 29.
PMID: 32346071RESULTChen Y, Li X, Zhang R, Xia Y, Shao Z, Mei Z. Effects of statin exposure and lung cancer survival: A meta-analysis of observational studies. Pharmacol Res. 2019 Mar;141:357-365. doi: 10.1016/j.phrs.2019.01.016. Epub 2019 Jan 11.
PMID: 30641276RESULTKhanzada UK, Pardo OE, Meier C, Downward J, Seckl MJ, Arcaro A. Potent inhibition of small-cell lung cancer cell growth by simvastatin reveals selective functions of Ras isoforms in growth factor signalling. Oncogene. 2006 Feb 9;25(6):877-87. doi: 10.1038/sj.onc.1209117.
PMID: 16170339RESULTHolstein SA, Hohl RJ. Synergistic interaction of lovastatin and paclitaxel in human cancer cells. Mol Cancer Ther. 2001 Dec;1(2):141-9.
PMID: 12467231RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice-Professor
Study Record Dates
First Submitted
July 26, 2021
First Posted
August 2, 2021
Study Start
November 1, 2021
Primary Completion
December 1, 2022
Study Completion
August 1, 2023
Last Updated
August 9, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share
IPD is not available to other researchers.