Secondary Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Recurrent Mucinous Ovarian Cancer (HI-MOC Study)

Korábbi kezelés

• Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of HIPEC (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
• Patients with a prior or concurrent malignancy who 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.
• History of prior HIPEC or intraperitoneal chemotherapy

Más betegség

• Patients with known hypersensitivity to any of the components of cisplatin
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• History of allogenic transplant
• Known bulky extra-abdominopelvic disease
• Patients with hearing impairment/tinnitus ≥ grade 2

Egyéb

• Patients with mucinous tumors with pathologic confirmation of a non-gynecologic site of origin
• Patients with known active CNS metastases
• Women who are pregnant or nursing women
• Patients with peripheral neuropathy ≥ grade 2

• Patients must have histologically or cytologically confirmed recurrent primary mucinous ovarian cancer
• Age ≥18 years
• ECOG performance status ≤ 2
• Prior to surgery, patients must have adequate organ and marrow function as defined below (within 30 days of registration):
  • absolute neutrophil count >1,500/mcL
  • platelets >100,000/mcL
  • total bilirubin ≤ 1.5 mg/dL
  • creatinine ≤ 1.5 mg/dL
  • AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal
• Patients must be > 2 weeks from prior chemotherapy or radiation therapy, except for bevacizumab treatment which requires >6 weeks
• Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)