Paclitaxel, Peritoneal Metastases, Stomach Neoplasms
Conditions
Keywords
Oxaliplatin, Capecitabine, XELOX
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.
Interventions
DRUGPaclitaxel
intraperitoneal paclitaxel 20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I) recommended dose (phase II)
Sponsors
Seoul St. Mary's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Conversion surgery rate | 6 months after start of treatment | rate of conversion surgery |
| Ascites response | 6 months after start of treatment | negative conversion rate of peritoneal cytology |
Countries
South Korea
Contacts
Primary ContactKabsoo Shin
Outcome results
None listed