Clinical trial NCT04943653: Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis
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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Stomach Neoplasms
Paclitaxel
Peritoneal Metastases
Keywords: Oxaliplatin
Capecitabine
XELOX
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 6-month progression free survival (6-month PFS)
timeFrame: 6 months after start of treatment
Secondary outcomes:
measure: 1-year overall survival (1-year OS)
timeFrame: 1 year after start of treatment
measure: Objective Response Rate (ORR)
timeFrame: 6 months after start of treatment
measure: Conversion surgery rate
timeFrame: 6 months after start of treatment
measure: Ascites response
timeFrame: 6 months after start of treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gastric cancer center, Seoul St. Mary's Hospital
Study officials:
References: