Clinical trial · Interventional
Intraperitoneal Docetaxel With Cisplatin and TS-ONE for Gastric Cancer With Peritoneal Carcinomatosis
Feasibility Study of Intraperitoneal Docetaxel Combined With Intravenous Cisplatin and Oral TS-ONE for Gastric Cancer Patients With Peritoneal Carcinomatosis
NCT02024841CI-TRIAL-00032787completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraperitoneal docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraperitoneal docetaxel
- description
- Intraperitoneal docetaxel in 1litre normal saline infused over 1 hour on day 1 every 3 weeks: \- Level I: 40mg/m2; Level II: 50mg/m2; Level III: 60mg/m2 Intravenous cisplatin: 60mg/m2 on day 1 every 3 weeks Oral TS-ONE: 40-60mg twice daily on day 1 -14 every 3 weeks
- interventionNames
- Drug: Intraperitoneal docetaxel
Primary outcomes (1)
- measure
- Maximum tolerated dose and recommended dose
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- Clinical response rate
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.