Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy

NCT04698941 | Unknown Phase 2

• 1 other identifier: 2020LY021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This Phase II study was designed to evaluate the safety and efficacy of albumin paclitaxel in combination with simvastatin compared with treatment with albumin paclitaxel alone in ES-SCLC patients relapsed from first-line chemotherapy. Participants will be divided in a 1:1 ratio to receive either albumin paclitaxel (4 cycles) + simvastatin (10 months) or albumin paclitaxel (4 cycles) until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or symptomatic deterioration.

Conditions

Small Cell Lung Cancer

Keywords

ES-SCLC; Chemo-resistance; Simvastatin

Outcome Measures

Primary Outcomes (1)

• Disease control rate (DCR)

  To assess disease control rate (DCR) after treatment.

  6 weeks

Secondary Outcomes (4)

• Overall response rate (ORR)

  6 weeks

• Progression-free survival (PFS)

  12 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 + Albumin Paclitaxel

EXPERIMENTAL

received intravenous infusions of Paclitaxel 260 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle (4 cycles) in combination with oral simvastatin (20mg daily) (10 months)

Drug: Albumin Paclitaxel; Drug: Simvastatin

Albumin Paclitaxel

ACTIVE COMPARATOR

received intravenous infusions of Paclitaxel 260 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle (4 cycles)

Drug: Albumin Paclitaxel

Interventions

Albumin Paclitaxel DRUG

Albumin Paclitaxel intravenous infusion was administered at a dose of 260 mg/m\^2 on Day 1 of each 21-day cycle.

Albumin Paclitaxel; Simvastatin + Albumin Paclitaxel

Simvastatin DRUG

20mg daily oral tablet taken.

Also known as: Simvastatin Tablets

Simvastatin + Albumin Paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• Chinese Academy of Sciences: collaborator

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

RECRUITING

Shanghai pulmonary hospital, Tongji University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

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: 33285097 BACKGROUND

• Gelsomino 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: 32346071 BACKGROUND

• Chen 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: 30641276 BACKGROUND

• Khanzada 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: 16170339 BACKGROUND

• Holstein SA, Hohl RJ. Synergistic interaction of lovastatin and paclitaxel in human cancer cells. Mol Cancer Ther. 2001 Dec;1(2):141-9.

  PMID: 12467231 BACKGROUND

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

• Yayi He, Doctor

  Shanghai Pulmonary Hospital, Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbin Ji, PHD

CONTACT

+86-21-54921108; hbji@sibcb.ac.cn

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: Professor

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 7, 2021
• Study Start: July 25, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

CN (2)