NCT03330028 - Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 27, 2017

Primary Completion Date

April 18, 2023

Study Completion Date

April 18, 2023

Conditions

Diseases of Oesophagus Stomach and Duodenum

Interventions

DRUG

Dexamethasone

10 mg by vein approximately 60 minutes before Paclitaxel.

DRUG

Diphenhydramine

50 mg by vein approximately 60 minutes before Paclitaxel.

DRUG

Famotidine

20 mg by vein approximately 60 minutes before Paclitaxel.

DRUG

Mitomycin C

Mitomycin C 30 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.

DRUG

Cisplatin

Cisplatin 200 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.

DRUG

Paclitaxel

"Starting dose of Paclitaxel is 20 mg/m2 in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.~Dose-escalation scheme of Paclitaxel is in increments of 5 mg/m2."

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors

lead

M.D. Anderson Cancer Center

OTHER