Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis
- Conditions
- Stomach NeoplasmsPeritoneal MetastasesPaclitaxel
- Interventions
- Registration Number
- NCT04943653
- Lead Sponsor
- Seoul St. Mary's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 61
-
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),
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intraperitoneal paclitaxel + XELOX Paclitaxel Intraperitoneal paclitaxel Day1, Day8 + \*XELOX \*XELOX ; Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2 IV Day1 q 3 weeks
- Primary Outcome Measures
Name Time Method 6-month progression free survival (6-month PFS) 6 months after start of treatment PFS is the time from date of first dose until the date of objective disease progression or death
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) 6 months after start of treatment Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.
Conversion surgery rate 6 months after start of treatment rate of conversion surgery
1-year overall survival (1-year OS) 1 year after start of treatment OS is the time from date of first dose until death due to any cause
Ascites response 6 months after start of treatment negative conversion rate of peritoneal cytology
Trial Locations
- Locations (1)
Gastric cancer center, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of