Status:
COMPLETED
Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Stage IV Gastric Cancer With Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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)
Eligibility Criteria
Inclusion
- Unresectable or metastatic advanced gastric adenocarcinoma confirmed by histology
- Peritoneal seeding proven by histology or cytology
- 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)
- Age 18 to 70 years old
- Eastern Cooperative Oncology Group performance status \<\_ 2
- Estimated life expectancy of more than 3 months
- Adequate bone marrow function (WBCs\>3,000/µL and absolute neutrophil count (ANC) \>1,500/µL and platelets\>100,000/µL),
- Adequate renal function: creatinine \< 1 x upper normal limit (UNL) or creatinine clearance \_\> 60ml/min
- 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)
- Written informed consent
Exclusion
- Contraindication to any drug contained in the chemotherapy regimen
- Other tumor type than adenocarcinoma
- Presence or history of CNS metastasis
- Gastric outlet or bowel obstruction
- Evidence of serious gastrointestinal bleeding
- Peripheral neuropathy \> grade 2
- History of significant neurologic or psychiatric disorders
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01525771
Start Date
February 1 2011
End Date
December 1 2014
Last Update
June 29 2015
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea