Fluoropyrimidine failure metastatic gastric cancer
Conditions
Interventions
Intravenous administration of paclitaxel 90 mg/m2 on Days 1, 8, and 15, every 4 weeks
Sponsors
Hiroshima Cancer Therapy Development Organization (HiCTDO)
Hiroshima Univ., Iwate Med. Univ.,Toyosu Hosp., Showa Univ., Kanagawa Cancer Ctr Hosp., Grad. Sch. Med., Hokkaido Univ., Kawakita Hosp., Grad. Sch. Med., Kobe Univ.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)With pathologically proven gastric cancer (2)With advanced gastric cancer resistant to fluoropyrimidines (up to 1 prior regimen other than fluoropyrimidines-based therapy) (3)With at least one measurable lesion (RECIST) (4)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as: white blood cell count>=4000 mm3, neutrophil count>=2000 mm3, hemoglobin>=9.0 g/dl, platelet>=100,000 mm3, AST and ALT within two times the upper limit of normal for the institution, serum bilirubin level=50 ml/min., C-reactive protein =28 days prior to entry (7)Life expectancy estimated>=12 weeks (8)Age 20-75 years (9)With collected tissue samples for pharmacogenomic analysis (10)With written informed consent
Exclusion criteria
Exclusion criteria: (1)With other serious disease: Ischemic heart disease, arrhythmia, Myocardiac infarction occurred within 6 month,Liver cirrhosis, Hemorrhage/bleeding>=grade3(NCI-CTC),Symptomatic psychological disease, Uncontrollable diabetes, Obstructive bowel disease (2)Active secondary cancer (3)A past history of drug allergy (4)A past history of allergic reaction to polyoxy-ethilen oil (5)Prior chemotherapy including a taxane (6)Peripheral neuropathy>=grade 2 in prior chemotherapy (7)Pregnancy or breast feeding (8)Ineligible decision by principal investigator (9)Active hepatitis or syphilis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Tumor response rate 2)Genotype-phenotype association (CYP3A4 and CYP2C8 vs toxicity), and expression-phenotype association (MDR1 and TUBB vs tumor response) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Adverse events, 2)Progression free-survival (PFS) 3)Overall survival (OS) 4)Genotype-phenotype association (CYP3A4 and CYP2C8 vs PK parameter) 5) Gene expression-phenotype association (MDR1 and TUBB vs PK parameter) 6) Possible pharmacogenomic factors other than CYP3A4, CYP2C8, MDR1, and TUBB | — |
Countries
Japan
Contacts
Public ContactMasahiko Nishiyama
Research Institute for Radiation Biology and Medicine, Hiroshima University Department of Translational Cancer Research
Outcome results
None listed