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

Primary Purpose

Stomach Neoplasms, Paclitaxel, Peritoneal Metastases

Status

Recruiting

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Paclitaxel

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Oxaliplatin, Capecitabine, XELOX

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
- 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

Sites / Locations

Gastric cancer center, Seoul St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraperitoneal paclitaxel + XELOX

Arm Description

Intraperitoneal paclitaxel Day1, Day8 + *XELOX *XELOX ; Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2 IV Day1 q 3 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

1-year overall survival (1-year OS)

OS is the time from date of first dose until death due to any cause

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.

Conversion surgery rate

rate of conversion surgery

Ascites response

negative conversion rate of peritoneal cytology

Full Information

NCT ID

NCT04943653

First Posted

June 21, 2021

Last Updated

July 1, 2021

Sponsor

Seoul St. Mary's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04943653

Brief Title

Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

June 8, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul St. Mary's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Neoplasms, Paclitaxel, Peritoneal Metastases

Keywords

Oxaliplatin, Capecitabine, XELOX

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intraperitoneal paclitaxel + XELOX

Arm Type

Experimental

Arm Description

Intraperitoneal paclitaxel Day1, Day8 + *XELOX *XELOX ; Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2 IV Day1 q 3 weeks

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

capecitabine, oxaliplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

6-month progression free survival (6-month PFS)

Description

PFS is the time from date of first dose until the date of objective disease progression or death

Time Frame

6 months after start of treatment

Secondary Outcome Measure Information:

Title

1-year overall survival (1-year OS)

Description

OS is the time from date of first dose until death due to any cause

Time Frame

1 year after start of treatment

Title

Objective Response Rate (ORR)

Description

Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.

Time Frame

6 months after start of treatment

Title

Conversion surgery rate

Description

rate of conversion surgery

Time Frame

6 months after start of treatment

Title

Ascites response

Description

negative conversion rate of peritoneal cytology

Time Frame

6 months after start of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kabsoo Shin

Phone

82-2-2258-6256

kabsoo.shin@catholic.ac.kr

Facility Information:

Facility Name

Gastric cancer center, Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kabsoo Shin

Phone

82-2-2258-6256

kabsoo.shin@catholic.ac.kr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

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