Intraperitoneal Paclitaxel With XELOX in Gastric Cancer With Peritoneal Metastasis
NCT ID: NCT04943653
Last Updated: 2021-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2021-06-08
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intraperitoneal paclitaxel + XELOX
Intraperitoneal paclitaxel Day1, Day8 + \*XELOX
\*XELOX ; Capecitabine 2000mg/m2/day(Day1-14) Oxaliplatin 100mg/m2 IV Day1 q 3 weeks
Paclitaxel
intraperitoneal paclitaxel
20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I)
recommended dose (phase II)
Interventions
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Paclitaxel
intraperitoneal paclitaxel
20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I)
recommended dose (phase II)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Seoul St. Mary's Hospital
OTHER
Responsible Party
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In-ho Kim
Associate proffessor
Locations
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Gastric cancer center, Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KC20MISF0813
Identifier Type: -
Identifier Source: org_study_id
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