Intraperitoneal Docetaxel With Cisplatin and TS-ONE for Gastric Cancer With Peritoneal Carcinomatosis

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I study on the maximum tolerated dose (MTD) and the recommended dose (RD) of intraperitoneal docetaxel combined with intravenous cisplatin and oral TS-ONE in gastric cancer patients with peritoneal carcinomatosis

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborator: Taiho Pharmaceutical Co., Ltd.
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• Age≥18

• Histologic confirmation of gastric adenocarcinoma

• Positive peritoneal cytology or histological proven PC

• Absence of other distant metastases except peritoneum and lymph node(s)

• Adequate bone marrow and organ functions as defined below:

• Leucocyte ≥3.00 x 109/L

• Absolute neutrophil counts ≥ 1.50 x 109/L

• Platelet ≥ 100 x 109/L

• Total bilirubin ≤2 x ULN

• AST/ALT ≤2.5 x ULN

• Creatinine clearance ≥60ml/min

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Subjects of child-bearing potential must agree to contraception from screening to 6 months after completion of treatment

• Provision of written informed consent

Exclusion Criteria:

• Any prior anti-cancer therapy for gastric cancer

• Previous exposure to taxane, fluoropyrimidine or platinum chemotherapy

• Previous radiotherapy to abdomen or pelvic region

• Known hypersensitivity to study medication

• Known dihydropyrimidine dehydrogenase (DPD) deficiency

• Any prior or synchronous malignancy, except,

• Malignancy treated with curative intent and with no evidence of disease for ≥5 years prior to enrollment and considered to be at low risk for recurrence by the treating physician

• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease

• Subject is pregnant or breast feeding

• Any serious concomitant illness