Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

Stomach Neoplasms Clinical Trial

— IPXELOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943653
• Other study ID #: KC20MISF0813
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 8, 2021
• Est. completion date: December 2025

Study information

• Verified date: July 2021
• Source: Seoul St. Mary's Hospital
• Contact: Kabsoo Shin
• Phone: 82-2-2258-6256
• Email: kabsoo.shin[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: December 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Paclitaxel
• Peritoneal Metastases
• Stomach Neoplasms

Intervention

Drug:
• Paclitaxel
intraperitoneal paclitaxel 20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I) recommended dose (phase II)

Locations

Country	Name	City	State
Korea, Republic of	Gastric cancer center, Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-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	6 months after start of treatment
Secondary	1-year overall survival (1-year OS)	OS is the time from date of first dose until death due to any cause	1 year after start of treatment
Secondary	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.	6 months after start of treatment
Secondary	Conversion surgery rate	rate of conversion surgery	6 months after start of treatment
Secondary	Ascites response	negative conversion rate of peritoneal cytology	6 months after start of treatment