Title

Discovery Stage IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms
Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer.
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Active, not recruiting
  • Intervention/Treatment

    etoposide ...
  • Study Participants

    600
Explore the relationship between drug target topoisomerase II gene single nucleotide polymorphisms and Etoposide (VP-16) therapeutic-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Etoposide (VP-16) side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.
The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus Methotrexate Injection plus Topotecan Injection, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

The study approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

1) Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients.
2) Mutually compare everyone patient drug target whole gene precision sequence for total 600 recruited double blind SCLC patients.
3) Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients.
4) Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
5) Correlate everyone patient drug target gene SNP to everyone patient drug safety.
6) Mutually compare the usual approach group SNPs (300 double blind random group separated SCLC patients) with the study approach group SNPs (300 double blind random group separated SCLC patients).
7) Confirm the relationship between drug target gene SNPs and drug efficacy.
8) Confirm the relationship between drug target gene SNPs and drug safety.
Study Started
Jan 31
2017
Primary Completion
Nov 30
2022
Anticipated
Study Completion
Dec 31
2022
Anticipated
Last Update
Sep 01
2021

Drug ETOPOSIDE - Usual

Etoposide Injection plus Methotrexate Injection plus Topotecan Injection

  • Other names: Etoposide Injection Combined Chemotherapy

Drug ETOPOSIDE - Study

Etoposide Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule

  • Other names: Etoposide Capsule Combined Chemotherapy

ETOPOSIDE - Usual Experimental

Etoposide Injection Combined Chemotherapy Etoposide Injection + Methotrexate Injection + Topotecan Injection Usual Approach Group

ETOPOSIDE - Study Experimental

Etoposide Capsule Combined Chemotherapy Etoposide Capsule + Methotrexate Tablet + HYCAMTIN - Topotecan Capsule Study Approach Group

Criteria

Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy
Duration at least 180 days
The usual approach group - Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection plus Methotrexate Injection plus Topotecan Injection after lung tissue biopsy, like as the usual approach group.
The study approach group - Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Capsule plus Methotrexate Tablet plus HYCAMTIN - Topotecan Capsule after lung tissue biopsy, like as the study approach group.

The inclusion criteria:

1. Clinical diagnosis of Small Cell Lung Cancer (SCLC)
2. Clinical lung tissue biopsy diagnosis of SCLC
3. Suitable for enough lung tissue biopsy of SCLC
4. Random and double blind
5. Measurable disease
6. Adequate organ functions
7 .Adequate performance status
8. Age 22 years old and over
9. Sign an informed consent form
10. Receive blood-drawing

The exclusion criteria:

1. Pneumonectomy
2. Treatment with other anti-cancer therapies and cannot be stopped currently
3. Pregnancy
4. Breast-feeding
5. The patients with other serious inter-current illness or infectious diseases
6. Have more than one different kind of cancer in the same time
7. Serious Allergy to Drugs
8. Serious Bleed Tendency
9. Serious Risks or Serious Adverse Events of the drug product
10. The prohibition of the drug product
11. Have no therapeutic effects
12. Follow up to the most current label
No Results Posted