Phase I,II Study of Intraperitoneal Paclitaxel with Capecitabine and Oxaliplatin Combination Therapy in Patients with Gastric Cancer with Peritoneal Metastasis

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005802

Enrollment

Registered

2021-01-21

Start date

2021-01-01

Completion date

Unknown

Last updated

2021-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Paclitaxel 60mg/m2 intraperitoneal Day1, Day8 + XELOX *XELOX

Drug : In phase 1, we use a 3+3 expanded cohort dose escalation until a predefined number of dose-limiting toxicities are reached. Patients will have an intraperitoneal catheter placed surgically afte

Paclitaxel 20mg/m2 intraperitoneal Day1, Day8 + XELOX Cohort 2

Paclitaxel 40mg/m2 intraperitoneal Day1, Day8 + XELOX Cohort 3

oral Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2, intravenous Day1 q 3 weeks In phase 2, Same dose and schedule of the XELOX as the phase I will be administered with the recommended do

oral Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2, intravenous Day1 q 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) age 20 to 80 years 2) ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1 3) Pathologically proven primary gastric adenocarcinoma 4) Peritoneal metastasis confirmed by laparoscopy or diagnostic imaging 5) Written informed consent 6) 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 T-Bilirubin <= = 2.0mg/dl or ULN x 1.5 AST <=100U/L ALT <=100U/L Creatinine clearance = 50mL/min

Exclusion criteria

Exclusion criteria: 1) Other active concomitant malignancies 2) HER2 positive (Immunohistochemostry 3+ or 2+ with in situ hybridization positive) 3) No investigational anticancer therapy within 30 days prior to the first dose of study treatment 4) recent (within 6 months) acute coronary syndrome, severe heart failure or severe pulmonary disease 5) uncontrolled acute or chronic disease 6) uncontrolled infection or inflammation 7) uncontrolled psychiatric disorder or central neurologic disease 8) not fully recovered from previous surgery 9) prior anticancer therapy (chemotherapy, immunotherapy, radiation) within 6 months 10) intolerable to oral administration or a lack of physical integration of the upper gastrointestinal tract or with a malabsorption syndrome 11) Fertile males and females who are unwilling to use effective contraceptive methods. 12) Pregnancy, breast feeding or intention to become pregnant 13) interstitial pneumonia or pulmonary fibrosis 14) Peripheral neuropathy with functional impairment 15) Hypersensitivity to paclitaxel, oxaliplatin, capecitabine, fluoropyrimidine or Cremophor EL. 16) concomitant therapy with any substrate or inhibitor of Cytochrome P450 2C8 or 3A4 17) Concomitant therapy with sorivudine or brivudine 18) Dihydropyrimidine dehydrogenase (DPD) deficiency. 19) Current or recent (within the 7 days prior to enrollment) treatment of tegafur-gimeracil-oteracil potassium

Design outcomes

Primary

Measure	Time frame
6-month progression-free survival rate;recommended phase 2 dose of intraperitoneal paclitaxel	—

Secondary

Measure	Time frame
adverse evenet according to Common Terminology Criteria for Adverse Events version 4.0;1-year overall survival rate;response rate;negative conversion rate on peritoneal cytology	—

Countries

Korea, Republic of

Contacts

Public ContactKabsoo Shin

The Catholic University of Korea, Seoul St. Mary's Hospital

Outcome results