Hyperthermic Intraperitoneal Chemotherapy in Treating Patients with Stage IIIB-IIIC Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Inclusion Criteria

• Ability to understand and the willingness to sign a written informed consent
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
• Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, stage IIIB – IIIC with optimal (=< 1 cm) residual disease. Patients will have eligibility confirmed and registered during surgery
• Patients with the following histologic epithelial cell types are eligible: * Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified
• No previous HIPEC
• Patient has a planned CC0 or CC1 cytoreduction – NOTE: registration occurs during surgery and not before; if, during surgery, the principal investigator (PI)/sub-investigator (SubI) discerns that all disease cannot be removed surgically, the participant will be considered a “screen failure”, HIPEC will not be performed, and the participant will be removed from the study
• Absolute neutrophil count >= 1.5 K/UL
• Platelets >= 100 K/UL
• Total bilirubin within 1.5 x normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 2.5 X institutional upper limit of normal
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
• Serum creatinine within =< 1.5mg/dL
• Creatinine clearance > 60 mg/mi (Cockcroft- Gault Equation)
• Blood urea nitrogen (BUN) < 25 mg/dL
• Women of child-bearing potential and their male partners also of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * NOTE: Acceptable forms of birth control are listed below: ** One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) ** PLUS ** Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T)

Exclusion Criteria

• Current or anticipated use of other investigational agents
• Patient has received chemotherapy or radiotherapy within 24 days prior to entering the study or has not recovered sufficiently (PI will judge patient recovery status) from adverse events due to agents administered more than 24 days earlier
• Patient has history of or currently has non-peritoneal surface macroscopic metastatic disease in addition to peritoneal surface malignancy such as macroscopic pulmonary disease or other macroscopic disease outside of the peritoneal cavity
• Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly “tumors of low malignant potential”) or recurrent invasive epithelial ovarian cancer treated with surgery only (such as those with stage Ia or Ib low grade lesions) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
• Synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: 1. Stage not greater than IB, 2. No more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
• Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. Subjects are also excluded if their previous cancer treatment contraindicates this protocol’s therapy
• History or current diagnosis of inflammatory bowel disease
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, carboplatin and paclitaxel or other agents used in study
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
• Current psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants