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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
intraperitoneal paclitaxel 20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I) recommended dose (phase II)
Gastric cancer center, Seoul St. Mary's Hospital
Seoul, South Korea
RECRUITING6-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
Time frame: 6 months after start of treatment
1-year overall survival (1-year OS)
OS is the time from date of first dose until death due to any cause
Time frame: 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.
Time frame: 6 months after start of treatment
Conversion surgery rate
rate of conversion surgery
Time frame: 6 months after start of treatment
Ascites response
negative conversion rate of peritoneal cytology
Time frame: 6 months after start of treatment
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