Carcinoma, Non-Small-Cell Lung

Erlotinib

Silybin-phytosome

Gosin University Gospel Hospital

A Phase II Study to Assess Efficacy of Combined Treatment With Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients With EGFR Mutant Lung Adenocarcinoma

A Phase II Study to Assess Efficacy of Combined Treatment With Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients With EGFR(Epidermal Growth Factor Receptor) Mutant Lung Adenocarcinoma

Efficacy assessment will be conducted through measurement of lesions by CT and RECIST criteria.

For toxicity assessment, posttreatment recurrence and survival rates will be investigated based on NCI-CTCAE ver 4.0 and RTOG.

Chang-gyu Choi

Manager

MedicalLogic

Kosin University Gospel Hospital

Subjects in this group will take Silibin-Phytosome 13 grams daily, in three divided doses for 2-10 weeks.

Patients in this arm will not take any intervention.

Subjects in this group received silybin-phytosome for 2-10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.

Silibin-Phytosome

Subjects in the control arm did not receive any treatment or placebo.

Control

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

To determine if measurable silibinin tissue levels are detectable in the prostate glands of men treated with Silybin-Phytosome administered according to the protocol. Analysis of silibinin in human fluid and tissue samples was carried out by Liquid chromatography - mass spectrometric (LC/MS/MS) following liquid extraction. Briefly, sample was extracted in acidified ethyl acetate by vortex. Following centrifugation, the organic layer was evaporated to dryness in a rotary evaporator and the samples were dissolved in acetonitrile/ammonium acetate with acetic acid for analysis. Sample analysis was done using an Applied Biosystems 3200 Q-Trap 1 triple quadrupole mass spectrometer with an Agilent 1100 Liquid Chromatography system and HTC-PAL Leap Autosampler. Quantitation of silibinin in samples was done by internal standard reference and batch analysis verified by the inclusion of spiked quality control samples in the appropriate matrix.

Measurable Silibinin Tissue Levels

Overall Study

Dr. Thomas Flaig

Prostate Cancer

Subjects will take Silibin-Phytosome for 2-10 weeks. The dose of Silibin-Phytosome is 13 grams daily, in three divided doses. Patients will be asked to mix 1 level teaspoon and 1 heaping ¼ teaspoon of Silybin-Phytosome powder into 6 tablespoons of applesauce for each dose.

Genitourinary care team at the University of Colorado

silybin/xərçəng xəstəliyi

A Phase II Study to Assess Efficacy of Combined Treatment With Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients With EGFR Mutant Lung Adenocarcinoma

The Effect of High-dose Silybin-phytosome in Men With Prostate Cancer

Elm tərəfindən dəstəklənən ən tam dərman bitkiləri bazası