Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

Study Overview
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Brief Summary
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IPXELOX will investigate the safety, tolerability, and antitumor activity of intraperitoneal paclitaxel in combination with chemotherapy in patients with advanced gastric cancer with peritoneal metastasis. Study hypotheses: Intraperitoneal paclitaxel administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and anti-tumor efficacy with systemic capecitabine and oxaliplatin in advanced gastric cancer with peritoneal metastasis.

Official Title
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Phase I,II Study of First Line Intraperitoneal Paclitaxel With Systemic Capecitabine and Oxaliplatin Combination Therapy in Patients With Advanced Gastric Cancer With Peritoneal Metastasis

Conditions
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Stomach Neoplasms, Paclitaxel, Peritoneal Metastases

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1 pathologically proven primary gastric adenocarcinoma peritoneal metastasis confirmed by laparoscopy or diagnostic imaging written informed consent adequate function of important organs (within 14 days before registration) Absolute neutrophil count ≥1.5 x 10^9/L, Platelet >=100,000/mm3, Hemoglobin >=8.0g/dL, Total bilirubin <= ≤ 2.0mg/dl or ULN(Upper Limit of Normal) x 1.5, AST(aspartate aminotransferase) <=100IU/L(International Unit/Liter), ALT(alanine transaminase) <=100IU/L, Creatinine clearance ≥ 50mL/min (milliliter/minute), Exclusion Criteria: other active concomitant malignancies HER2(human epidermal growth factor receptor 2) positive (Immunohistochemistry 3+ or 2+ with in situ hybridization positive) no investigational anticancer therapy within 30 days prior to the first dose of study treatment recent (within 6 months) acute coronary syndrome, severe heart failure or severe pulmonary disease uncontrolled acute or chronic disease uncontrolled infection or inflammation uncontrolled psychiatric disorder or central neurologic disease not fully recovered from previous surgery prior anticancer therapy (chemotherapy, immunotherapy, radiation) within 6 months intolerable to oral administration or a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome fertile males and females who are unwilling to use effective contraceptive methods. pregnancy, breast feeding or intention to become pregnant interstitial pneumonia or pulmonary fibrosis peripheral neuropathy with functional impairment hypersensitivity to paclitaxel, oxaliplatin, capecitabine, fluoropyrimidine or Cremophor EL. concomitant therapy with any substrate or inhibitor of Cytochrome P450 2C8 or 3A4 concomitant therapy with sorivudine or brivudine Dihydropyrimidine dehydrogenase (DPD) deficiency. current or recent (within the 7 days prior to enrollment) treatment of tegafur-gimeracil-oteracil potassium

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Intraperitoneal paclitaxel + XELOX<br>Intraperitoneal paclitaxel Day1, Day8 + *XELOX *XELOX ; Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2 IV Day1 q 3 weeks | Drug: Paclitaxel<br>* intraperitoneal paclitaxel 20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I) recommended dose (phase II)<br>* Other names: oxaliplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month progression free survival (6-month PFS) | PFS is the time from date of first dose until the date of objective disease progression or death | 6 months after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year overall survival (1-year OS) | OS is the time from date of first dose until death due to any cause | 1 year after start of treatment | 
| Objective Response Rate (ORR) | Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed. | 6 months after start of treatment | 
| Conversion surgery rate | rate of conversion surgery | 6 months after start of treatment | 
| Ascites response | negative conversion rate of peritoneal cytology | 6 months after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxaliplatin, Capecitabine, XELOX