Using intraperitoneal paclitaxel with XELOX for advanced 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
This study is testing if a new treatment combining intraperitoneal paclitaxel with XELOX can help people with advanced gastric cancer that has spread to the lining of the abdomen.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Seoul St. Mary's Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04943653 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety, tolerability, and anti-tumor activity of intraperitoneal paclitaxel combined with the chemotherapy regimen XELOX (oxaliplatin and capecitabine) in patients suffering from advanced gastric cancer with peritoneal metastasis. Participants will receive the treatment at a recommended phase 2 dose, and the study aims to assess both the effectiveness and side effects of this approach. The study is designed for patients with confirmed peritoneal metastasis and aims to provide a new therapeutic option for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates include individuals with pathologically proven primary gastric adenocarcinoma and confirmed peritoneal metastasis who have a good performance status.
Not a fit: Patients with HER2 positive gastric cancer or other active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced gastric cancer and peritoneal metastasis.
How similar studies have performed: While this approach is novel, similar studies have shown promise in using intraperitoneal chemotherapy for other cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Gastric cancer center, Seoul St. Mary's Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Kabsoo Shin
- Email: kabsoo.shin@catholic.ac.kr
- Phone: 82-2-2258-6256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.