A phase I/II study of weekly paclitaxel therapy for metastatic gastric cancer (Step 2)

UMIN ID: C000000101

Registered date:01/10/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Fluoropyrimidine failure metastatic gastric cancer
• Date of first enrollment: 2004/04/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intravenous administration of paclitaxel 90 mg/m2 on Days 1, 8, and 15, every 4 weeks

Outcome(s)

• Primary Outcome: 1)Tumor response rate 2)Genotype-phenotype association (CYP3A4 and CYP2C8 vs toxicity), and expression-phenotype association (MDR1 and TUBB vs tumor response)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Hiroshima Cancer Therapy Development Organization (HiCTDO)
• Secondary Sponsor: 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.
• Source(s) of Monetary Support: Hiroshima Cancer Therapy Development Organization (HiCTDO),None
• Secondary ID(s): HiCTDO protocol #1