Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis (IPXELOX)

July 1, 2021 updated by: In-ho Kim, Seoul St. Mary's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

61

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraperitoneal paclitaxel + XELOX

Intraperitoneal paclitaxel Day1, Day8 + *XELOX

*XELOX ; Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2 IV Day1 q 3 weeks
Drug: Paclitaxel

intraperitoneal paclitaxel

20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I)

recommended dose (phase II)

Other Names:
  • oxaliplatin
  • capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month progression free survival (6-month PFS)
Time Frame: 6 months after start of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year overall survival (1-year OS)
Time Frame: 1 year after start of treatment
OS is the time from date of first dose until death due to any cause
1 year after start of treatment
Objective Response Rate (ORR)
Time Frame: 6 months after start of treatment
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
Conversion surgery rate
Time Frame: 6 months after start of treatment
rate of conversion surgery
6 months after start of treatment
Ascites response
Time Frame: 6 months after start of treatment
negative conversion rate of peritoneal cytology
6 months after start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 29, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC20MISF0813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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