Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Summary
The goal of this clinical research study is to find the highest tolerable dose of paclitaxel that can be given as hyperthermic intraperitoneal chemotherapy (HIPEC) to patients with gastric or gastroesophageal cancer. HIPEC is a system in which heated chemotherapy is delivered directly inside the abdomen during surgery. In this study, paclitaxel is being combined with mitomycin and cisplatin to see if this study drug combination can help to control the disease. This is an investigational study. Mitomycin, cisplatin, and paclitaxel are FDA-approved and commercially available for the treatment of gastric and gastroesophageal cancer. It is investigational to give these drugs by HIPEC. The study doctor can describe how the study drugs and HIPEC are designed to work. Up to 48 participants will be enrolled in this study. All will take part at MD Anderson.
Timeline
- Start
- 2017-10-27
- Primary completion
- 2023-04-18
- Completion
- 2023-04-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 20 mg/m2 | Other |
| Background | Cisplatin | Other / unclassified | 200 mg | Other |
| Background | Dexamethasone | Small molecule | 10 mg | Intravenous |
| Background | Diphenhydramine | Unknown | 50 mg | Intravenous |
| Background | Famotidine | Other / unclassified | 20 mg | Intravenous |
| Background | Mitomycin C | Other / unclassified | 30 mg | Other |