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Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Stomach Cancer with Peritoneal Metastases

Trial Status: Active

This phase IIa trial studies how well HIPEC works in treating patients with stomach cancer that has spread to the abdominal cavity (peritoneal metastases). HIPEC involves the infusion of a heated chemotherapy solution that circulates into the abdominal cavity. Drugs used in chemotherapy, such as cisplatin and mitomycin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC with cisplatin and mitomycin may be able to change protein expression in stomach cancer, as well as change the amount of disease in the abdominal cavity.

Inclusion Criteria

  • Patients with histologically confirmed gastric cancer and peritoneal metastases (GC/PM) only and/or positive peritoneal cytology, who have completed prior systemic chemotherapy for a minimum of 2 to 4 months duration
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin =< institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 3 x institutional ULN
  • Creatinine =< institutional ULN OR glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^3
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Expected survival greater than 3 months
  • Because cisplatin and mitomycin C are pregnancy category D and potentially teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of the study
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Patients with coexistence of another untreated malignant neoplasm other than basal cell carcinoma of the skin within the last five years
  • Sites of metastases other than loco-regional lymph nodes and peritoneum (ex. visceral metastases such as liver, lungs, bone, brain)
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
  • Patients who are receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin and mitomycin C
  • Patients with uncontrolled intercurrent illness
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because cisplatin and mitomycin C are class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin and mitomycin C, breastfeeding should be discontinued if the mother is treated with cisplatin and mitomycin C

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Oliver Eng
Phone: 773-702-4897

PRIMARY OBJECTIVE:

I. To examine if PD-L1 expression can be upregulated in peritoneal metastases from gastric cancer after the administration of hyperthermic intraperitoneal chemotherapy (HIPEC) with greater frequency compared to systemic chemotherapy alone.

SECONDARY OBJECTIVES:

I. To examine the rate of conversion to resectability with repeated interval laparoscopic HIPEC as defined by the Phase II trial published by Badgwell et al.

II. To quantitatively assess peritoneal cancer index (PCI) change with repeated interval laparoscopic HIPEC.

III. To examine overall survival from diagnosis of metastatic disease.

IV. To assess perioperative morbidity and mortality at 30 days.

OUTLINE:

Patients undergo HIPEC with cisplatin and mitomycin over 60 minutes. After 6 weeks, patients may repeat HIPEC with cisplatin and mitomycin over 60 minutes once in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every week or month for 3 months, and then every 1-3 months thereafter.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
University of Chicago Comprehensive Cancer Center

Principal Investigator
Oliver Eng

  • Primary ID IRB19-0160
  • Secondary IDs NCI-2019-08764
  • Clinicaltrials.gov ID NCT04107077