Stage IV Gastric Cancer With Metastasis
Conditions
Keywords
Advanced Gastric cancer, Xeloda (Capecitabine), Cisplatin, Taxotere (Docetaxel)
Brief summary
A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.
Detailed description
Single-center, open-label, prospective, single-arm, phase I-II study About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)
Interventions
OTHERDocetaxel
The study medication will be administered every 3 weeks for a maximum of 8cycles. A study medication will be given to the patients. * Docetaxel (-1 to 3 level)mg/m2 IV(D1) every 21 days (-1 level: 40, 1 level: 60, 2 level: 80, 3 level: 100) * Xeloda 937.5 mg/m2/ day PO, twice a day(D1-D14) every 21 days * Cisplatin 60mg/m2 IV (D1) every 21 days
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology 2. Peritoneal seeding proven by histology or cytology 3. Completion of adjuvant chemotherapy 6 months before the study, or no previous chemotherapy (But, patients who received docetaxel or cisplatin as adjuvant chemotherapy should be excluded) 4. Age 18 to 70 years old 5. Eastern Cooperative Oncology Group performance status \<\_ 2 6. Estimated life expectancy of more than 3 months 7. Adequate bone marrow function (WBCs\>3,000/µL and absolute neutrophil count (ANC) \>1,500/µL and platelets\>100,000/µL), 8. Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance \_\> 60ml/min 9. Adequate hepatic function: bilirubin \< 1.5 x UNL, AST/ALT levels \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL (except in case of bone metastasis without any liver disease) 10. Written informed consent
Exclusion criteria
1. Contraindication to any drug contained in the chemotherapy regimen 2. Other tumor type than adenocarcinoma 3. Presence or history of CNS metastasis 4. Gastric outlet or bowel obstruction 5. Evidence of serious gastrointestinal bleeding 6. Peripheral neuropathy \> grade 2 7. History of significant neurologic or psychiatric disorders 8. History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix 9. Pregnant or lactating women, women of childbearing potential not employing adequate contraception 10. Other serious illness or medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose | 1 year | Phase I Study \- Maximum tolerated dose of Intraperitoneal Docetaxel Phase II Study * Progression-free survival rate at 6 months * response rate, time to progression, overall survival |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile | 1 year |
| Overall survival | 1 year |
| Progression free survival | 1 year |
| efficacy | 1 year |
Countries
South Korea
Outcome results
None listed