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

Seoul St. Mary's Hospital1 site in 1 country61 target enrollmentJune 8, 2021

ConditionsStomach Neoplasms Paclitaxel Peritoneal Metastases

InterventionsPaclitaxel

DrugsPaclitaxel

Overview

Phase: Phase 1
Intervention: Paclitaxel
Conditions: Stomach Neoplasms
Sponsor: Seoul St. Mary's Hospital
Enrollment: 61
Locations: 1
Primary Endpoint: 6-month progression free survival (6-month PFS)
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 8, 2021

End Date

December 2025

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seoul St. Mary's Hospital

Responsible Party

Principal Investigator

In-ho Kim

Associate proffessor

Seoul St. Mary's Hospital

Eligibility Criteria

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),

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