IPXELOX: Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

• Sponsor: Seoul St. Mary's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04943653
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 53.8
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms; Paclitaxel; Peritoneal Metastases	Drug: Paclitaxel	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 8, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

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: capecitabine oxaliplatin

Outcome Measures

Primary Outcome Measures

1. 6-month progression free survival (6-month PFS) [6 months after start of treatment]

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

Secondary Outcome Measures

1. 1-year overall survival (1-year OS) [1 year after start of treatment]

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

2. Objective Response Rate (ORR) [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.

3. Conversion surgery rate [6 months after start of treatment]

   rate of conversion surgery

4. Ascites response [6 months after start of treatment]

   negative conversion rate of peritoneal cytology

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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),

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastric cancer center, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591

Sponsors and Collaborators

• Seoul St. Mary's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: In-ho Kim, Associate proffessor, Seoul St. Mary's Hospital
• ClinicalTrials.gov Identifier: NCT04943653
• Other Study ID Numbers: KC20MISF0813
• First Posted: Jun 29, 2021
• Last Update Posted: Jul 6, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by In-ho Kim, Associate proffessor, Seoul St. Mary's Hospital: Oxaliplatin; Capecitabine; XELOX
• Additional relevant MeSH terms: Neoplasm Metastasis; Stomach Neoplasms; Paclitaxel; Capecitabine; Oxaliplatin

Study Results

No Results Posted as of Jul 6, 2021