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

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0005802
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 January 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 61

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6-month progression-free survival rate;recommended phase 2 dose of intraperitoneal paclitaxel

Secondary Outcome Measures

Name	Time	Method
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