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

Primary Purpose

Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Albumin Paclitaxel
Simvastatin
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring ES-SCLC, Chemo-resistance, Simvastatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system).
  3. No patients with resectable or radical radiotherapy lung cancer.
  4. 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.
  5. Patient must be at least resistant to the first-line chemotherapy.
  6. Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  7. Patients can tolerate chemotherapy.

Exclusion Criteria:

  1. Unclear diagnosis of SCLC.
  2. Resectable or radical radiotherapy SCLC.
  3. Contraindicated chemotherapy.
  4. 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.
  5. Positive test result for human immunodeficiency virus (HIV).
  6. Positive test result for active tuberculosis.
  7. Live vaccine was administered within 28 days of initial administration. Inactivated viral vaccines for seasonal influenza are allowed, except for live attenuated intranasal vaccines.
  8. Pregnant or lactating women.
  9. A history of psychotropic substance abuse, drug abuse, or alcoholism.
  10. Other factors assessed by the sponsors.

Sites / Locations

  • CAS Center for Excellence in Molecular Cell Science, Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of SciencesRecruiting
  • Shanghai pulmonary hospital, Tongji UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simvastatin + Albumin Paclitaxel

Albumin Paclitaxel

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Disease control rate (DCR)
To assess disease control rate (DCR) after treatment.

Secondary Outcome Measures

Overall response rate (ORR)
To assess best overall response rate (ORR) after treatment.
Progression-free survival (PFS)
To evaluate the progression-free survival (PFS) of patients with extensive stage small cell lung cancer (ES-SCLC) treated with paclitaxel + simvastatin or with paclitaxel alone.
Overall survival (OS)
To estimate overall survival (OS) of patients with ES-SCLC.
Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v4.0
To evaluate the toxicity profile.

Full Information

First Posted
December 30, 2020
Last Updated
July 26, 2021
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Collaborators
Chinese Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04698941
Brief Title
Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy
Official Title
Clinical Study of Albumin Paclitaxel With or Without Simvastatin in Treating Extensive-Stage Small Cell Lung Cancer Patients Relapsed From First-line Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 25, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Collaborators
Chinese Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVES: I.To assess disease control rate (DCR) after treatment. SECONDARY OBJECTIVES: I.To assess best overall response rate (ORR) after treatment. II.To evaluate the progression-free survival (PFS) of patients with extensive stage-small cell lung cancer (ES-SCLC) treated with albumin paclitaxel + simvastatin or with albumin paclitaxel alone. III.To estimate overall survival (OS) of patients with ES-SCLC. IV. To evaluate the toxicity profile of albumin paclitaxel + simvastatin. EXPLORATORY OBJECTIVES: I.To evaluate biomarkers correlatives. II.To explore the mechanism of albumin paclitaxel + simvastatin in the treatment of chemotherapy-resistant participants with ES-SCLC. OUTLINE: Patients are divided into two arms. ARM A: Participants received intravenous infusions of albumin paclitaxel 260 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle in combination with oral simvastatin (20mg daily) until persistent radiographic PD as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or symptomatic deterioration. ARM B:Participants received intravenous infusions of albumin paclitaxel 260 mg/m^2 alone on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
ES-SCLC, Chemo-resistance, Simvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin + Albumin Paclitaxel
Arm Type
Experimental
Arm Description
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)
Arm Title
Albumin Paclitaxel
Arm Type
Active Comparator
Arm Description
received intravenous infusions of Paclitaxel 260 milligrams per square meter (mg/m^2) on Day 1 of every 21-day cycle (4 cycles)
Intervention Type
Drug
Intervention Name(s)
Albumin Paclitaxel
Intervention Description
Albumin Paclitaxel intravenous infusion was administered at a dose of 260 mg/m^2 on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Simvastatin Tablets
Intervention Description
20mg daily oral tablet taken.
Primary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
To assess disease control rate (DCR) after treatment.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
To assess best overall response rate (ORR) after treatment.
Time Frame
6 weeks
Title
Progression-free survival (PFS)
Description
To evaluate the progression-free survival (PFS) of patients with extensive stage small cell lung cancer (ES-SCLC) treated with paclitaxel + simvastatin or with paclitaxel alone.
Time Frame
12 weeks
Title
Overall survival (OS)
Description
To estimate overall survival (OS) of patients with ES-SCLC.
Time Frame
24 weeks
Title
Number of participants with treatment-related adverse events (AE) as assessed by CTCAE v4.0
Description
To evaluate the toxicity profile.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongbin Ji, PHD
Phone
+86-21-54921108
Email
hbji@sibcb.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yayi He, Doctor
Organizational Affiliation
Shanghai Pulmonary Hospital, Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAS Center for Excellence in Molecular Cell Science, Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbin Ji, PHD
Facility Name
Shanghai pulmonary hospital, Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yayi He, Doctor

12. IPD Sharing Statement

Citations:
PubMed Identifier
33285097
Citation
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Results Reference
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PubMed Identifier
32346071
Citation
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. Erratum In: Br J Cancer. 2021 Jul;125(2):306.
Results Reference
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PubMed Identifier
30641276
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
12467231
Citation
Holstein SA, Hohl RJ. Synergistic interaction of lovastatin and paclitaxel in human cancer cells. Mol Cancer Ther. 2001 Dec;1(2):141-9.
Results Reference
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Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy

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