Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer

Study Overview
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Brief Summary
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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
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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)

Official Title
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A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding

Conditions
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Stage IV Gastric Cancer With Metastasis

Intervention / Treatment
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* Other: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>Single-center, open-label, prospective, single-arm, phase I-II study | Other: Docetaxel<br>* 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<br>* Other names: Cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile |  | 1 year | 
| Overall survival |  | 1 year | 
| Progression free survival |  | 1 year | 
| efficacy |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Gastric cancer, Xeloda (Capecitabine), Cisplatin, Taxotere (Docetaxel)