Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis

NCT04943653 | Unknown Phase 1 DMC

• 1 other identifier: KC20MISF0813
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Neoplasms; Paclitaxel; Peritoneal Metastases

Keywords

Oxaliplatin; Capecitabine; XELOX

Outcome Measures

Primary Outcomes (1)

• 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

  6 months after start of treatment

Secondary Outcomes (4)

• 1-year overall survival (1-year OS)

  1 year after start of treatment

• Objective Response Rate (ORR)

  6 months after start of treatment

• Conversion surgery rate

  6 months after start of treatment

• Ascites response

  6 months after start of treatment

Study Arms (1)

Intraperitoneal paclitaxel + XELOX

EXPERIMENTAL

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

Drug: Paclitaxel

Interventions

Paclitaxel DRUG

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

Also known as: capecitabine, oxaliplatin

Intraperitoneal paclitaxel + XELOX

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Gastric cancer center, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes

Central Study Contacts

Kabsoo Shin

CONTACT

82-2-2258-6256; kabsoo.shin@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate proffessor

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: June 8, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)