Discovery Stage IND Clinical Study - Etoposide OS Plus Methotrexate OS and Single Nucleotide Polymorphisms

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 600
• Participant gender: All

Summary

• Correlate Topoisomerase II Gene Single Nucleotide Polymorphisms (SNPs) to Using Etoposide Therapeutic Effects of Treating Small Cell Lung Cancer (SCLC)

• Correlate CYP450 3A4 Gene Single Nucleotide Polymorphisms (SNPs) to Using Etoposide Side Effects of Treating Small Cell Lung Cancer (SCLC)

• Correlate Dihydrofolic-Acid Reductase Gene Single Nucleotide Polymorphisms (SNPs) to Using Methotrexate Therapeutic Effects of Treating Small Cell Lung Cancer (SCLC)

• Correlate Dihydrofolate Reductase Gene Single Nucleotide Polymorphisms (SNPs) to Using Methotrexate Side Effects of Treating Small Cell Lung Cancer (SCLC)

• Correlate Thymidylate Synthetase Gene Single Nucleotide Polymorphisms (SNPs) to Using Methotrexate Side Effects of Treating Small Cell Lung Cancer (SCLC)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Han Xu, M.D., Ph.D., Non-Investigator, IRB Chair
• Treatments: Etoposide; Etoposide phosphate; Everolimus; Methotrexate; Sirolimus; Topotecan
• Last Updated: 2017-11-20

Criteria

• Select 600 Small-Cell Lung Cancer (SCLC) Patients

• 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 CAPSULE plus METHOTREXATE TABLET plus TOPOTECAN HYDROCHLORIDE CAPSULE after local therapy with surgery, 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 EVEROLIMUS TABLET after local therapy with surgery, like as the study approach group.

• Inclusion Criteria:

• 1. Clinical diagnosis of small cell lung cancer

• 2. Clinical biopsy diagnosis of small cell lung cancer

• 3. Suitable for local therapy with surgery

• 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

• Exclusion Criteria:

• 1. Treatment with other anti-cancer therapies and cannot be stopped currently

• 2. Pregnancy

• 3. Breast-feeding

• 4. The patients with other serious inter-current illness or infectious diseases

• 5. Have more than one different kind of cancer in the same time

• 6. Serious Allergy to Lipids

• 7. Serious Bleed Tendency

• 8. The prohibition of the drug product