colorectal cancer/ gastric cancer
Conditions
Interventions
Administraion of CPT-11 is twice for 4 weeks on days 1 and 15. CPT-11 is reconstituted in >
=250 mL of normal saline or 5% dextrose in water and infuse 90min on day 1 for pharmacokinetics, and 90min over on day15. CPT-11 adjusted dosage is determined from 50,75,100,125 or 150mg/sqm in the he
Sponsors
Yakult Honsha Co.,Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed colorectal and gastric cancer 2)Metastatic colorectal cancer and locally advanced and/or metastatic gastric cancer 3)Testing confirmed UGT1A1*28 and UGT1A1*6 polymorphisms 4)Having prior chemotherapy as standard regimens 5)Wash out:>=14 days for operation, and >=21 days for chemotherapy and/or radiotherapy 6)No prior irinotecan containing treatment 7)Age:>=20 years old at wiritten informed concent 8)PS(ECOG):0 to 1 9)A life expectancy for at least 2 months 10)Aduquate main organ (bone marrow, heart, pulumonary, liver, renal) function (1)WBC 3,000-12,000/mm^3,(2)Neutrophil >=1500/mm^3,(3)Hb >=8.5mg/dL,(4)Platelet >=100,000/mm^3,(5)AST <=100IU/L,(6)ALT <=100IU/L,(7)T-bilirubin <=2.0mg/dL,(8)serum creatinine <=1.50mg/dL 11)Written informed consent
Exclusion criteria
Exclusion criteria: 1)History of serious drug allergy 2)Active concomitant malignancy 3)Prior extensively irradiation for abdominal or bowel bone marrow 4)Symptomatic brain metastasis 5)Systemic continual use of steroids 6)Active infection 7)Persistent diarrhea (watery stool) 8)Intestinal obstraction or paralytic ileus 9)Interstitial pneumonia or pulmonary fibrosis 10)Massive pleural, pericardial effusion or asites that required drainage 11)Need to treatment with atazanavir sulfate 12)Uncontrolled diabetes mellitus 13)Heart disease deemed to unacceptable by diagnosis of cardiogram within the previous 28 days before enrollment 14)Psychological disease deemed to unacceptable for inclusion to the study 15)Pregnant or lactating women, couple wishing pregnant or no mind of prevent pregnancy 16)Other concominant medical condition deemed to inadequate for inclusion to the study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Recommended dose and dose limiting toxicity for heterozygous group and the homozygous groups, respectively. Incidence grade and frequency of toxicity. Pharmacokinetics of CPT-11, APC, SN-38 and SN-38G. Genetic polymorphisms analysis of UGT1A1,UGT1A7,UGT1A9 and OATP1B1 related to PK of CPT-11 and metabolites. | — |
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose for the heterozygous group and the homozygous group, respectively. Incidence rate of dose limiting toxicities for the wild group. | — |
Countries
Japan
Contacts
Public ContactShinji Sugimoto
Yakult Honsha Co.,Ltd Post Marketing Development, Pharmaceutical Department Department
Outcome results
None listed