Study of Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

• Status: Active, not recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Albumin-Bound Paclitaxel; BB 1101; Cisplatin; Dexamethasone; Dexamethasone acetate; Diphenhydramine; Famotidine; Mitomycin; Mitomycins; Paclitaxel; Promethazine

Criteria

Inclusion Criteria:

1. Age 18 years and above. There will be no upper age restriction.

2. Eastern Cooperative Oncology Group (ECOG) performance status

3. Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction.

4. Adequate renal, and bone marrow function: a. Leukocytes >= 3,000/uL b. Absolute neutrophil count >= 1,500/uL c. Platelets >= 60,000/Ul d. Serum creatinine <= 1.5 mg/dL

5. Distant Metastatic Disease of peritoneum: a. Positive peritoneal cytology b. Carcinomatosis on diagnostic laparoscopy or laparotomy.

6. Completion of preoperative systemic chemotherapy.

Exclusion Criteria:

1. Infections such as pneumonia or wound infections that would preclude protocol therapy.

2. Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.

3. Subjects with unstable angina or New York Heart Association Grade II or greater congestive heart failure.

4. Subjects deemed unable to comply with study and/or follow-up procedures.

5. Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity.