Clinical trial NCT01064466: Pharmacogenomics IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms
Official title: Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Small Cell Lung Cancer
Keywords: SCLC
Etoposide
SNP
Topo
CYP
Genotype
Oncology
Genetics
Lung
Cancer
Lead sponsor: Medicine Invention Design, Inc
Sponsor class: INDUSTRY
Collaborators: name: UnitedHealthcare
First posted: 2010-02-08
Enrollment: 600
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * The usual approach group (injection)
* The study approach group (oral)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide 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, 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 a total of 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.

Eligibility criteria: * Select 600 Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy
* Dosage Duration at least 45 days
* The usual approach group - Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide 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 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 intercurrent illness or infectious diseases
* 6. Have more than one different kind of cancer at 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 drug products
* 11. Have no therapeutic effects
* 12. Follow up to the most current label

Primary outcomes:
measure: Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
timeFrame: Duration at least 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
state: Maryland
Study officials:
affiliation: Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
name: HAN XU, MD/PhD/FAPCR
role: PRINCIPAL_INVESTIGATOR
affiliation: Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
name: HAN XU, MD/PhD/FAPCR
role: STUDY_DIRECTOR
affiliation: Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
name: HAN XU, MD/PhD/FAPCR
role: STUDY_CHAIR
References: