Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul St. Mary's Hospital
• Treatments: Capecitabine; Oxaliplatin; Paclitaxel

Criteria

1. 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),

2. 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