Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer

Inclusion Criteria:

• Patients with histologically confirmed GC/PM only and/or positive peritonealcytology, who have completed prior systemic chemotherapy for a minimum of 2 to 4months duration.

• Age ≥18 years. Because no dosing or adverse event data are currently available onthe use of HIPEC for GC/PM in patients under 18 years of age, children are excludedfrom this study, but will be eligible for future pediatric trials.

• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).

• Patients must have adequate organ and marrow function as defined below:

• leukocytes ≥3,000/mcL

• absolute neutrophil count ≥1,500/mcL

• platelets ≥100,000/mcL

• total bilirubin ≤ institutional upper limit of normal (ULN)

• AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN

• creatinine ≤ institutional ULN OR

• glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data existssupporting safe use at lower kidney function values, no lower than 30mL/min/1.73 m2 (see Appendix B).

• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviraltherapy with undetectable viral load within 6 months are eligible for this trial.

• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBVviral load must be undetectable on suppressive therapy, if indicated.

• Patients with a history of hepatitis C virus (HCV) infection must have been treatedand cured. For patients with HCV infection who are currently on treatment, they areeligible if they have an undetectable HCV viral load.

• Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial.

• Patients with known history or current symptoms of cardiac disease, or history oftreatment with cardiotoxic agents, should have a clinical risk assessment of cardiacfunction using the New York Heart Association Functional Classification. To beeligible 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 potentiallyteratogenic, women of child-bearing potential and men must agree to use adequatecontraception (hormonal or barrier method of birth control; abstinence) prior tostudy entry and for the duration of study participation. Should a woman becomepregnant or suspect she is pregnant while she or her partner is participating inthis study, she should inform her treating physician immediately. Men treated orenrolled on this protocol must also agree to use adequate contraception prior to thestudy, for the duration of study participation, and 4 months after completion of thestudy.

• Ability to understand and the willingness to sign a written informed consentdocument.

Exclusion Criteria:

• Patients with coexistence of another untreated malignant neoplasm other than basalcell 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 orbiologic composition to cisplatin and Mitomycin C.

• Patients with uncontrolled intercurrent illness.

• Patients with psychiatric illness/social situations that would limit compliance withstudy requirements.

• Pregnant women are excluded from this study because cisplatin and Mitomycin C areclass D agents with the potential for teratogenic or abortifacient effects. Becausethere is an unknown but potential risk for adverse events in nursing infantssecondary to treatment of the mother with cisplatin and Mitomycin C, breastfeedingshould be discontinued if the mother is treated with cisplatin and Mitomycin C.