Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy (HIPEC/IPHC)
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
PATIENT ELIGIBILITY
Presumptive clinical diagnosis of a peritoneal surface cancer (PSC) prior to surgery, with no metastases outside of the abdomen.
Patients must have a performance status of 0, 1, or 2.
Patients must have adequate:
Bone marrow function: absolute neutrophil count more than or equal to 1500 and platelet count more than or equal to 100,000 Renal function: creatinine less than or equal to 1.5 mg/dl Hepatic function: bilirubin less than or equal 1.5times upper limit of normal, SGOT and alkaline phosphatase less than or equal 2.5 times upper limit of normal range Patients must have signed an informed consent. Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception.
Patients are at least 18 years of age, and under 75 years of age.
At the time of surgery, operative assessment and frozen section diagnosis of one of the following:
Primary ovarian cancer (POC) with Stage IC or greater stage Recurrent or persistent ovarian cancer (ROC) Ovarian cancer patients who desire Consolidation Chemotherapy (CC). These patients would ordinarily choose to have 12 cycles of Taxol given after standard first-line surgery and chemotherapy, and instead choose one course of IPHC as their CC.
Uterine malignancy of the corpus, or cervix with primary tumor Stage IIIA or greater, or recurrent tumor confined to the abdomen.
Metastatic mesothelioma or sarcoma confined to the abdomen. Recurrent or primary gastrointestinal cancer, with regional spread confined to the peritoneal cavity
PATIENT INELIGIBILITY
Patients with known extra-abdominal disease, or unresected bulky abdominal retroperitoneal lymph nodes.
Patients with any evidence of another malignancy within the last five years (except non-melanoma skin cancer) Patients with a known sensitivity to cisplatin, Mitomycin C, or Adriamycin. Patients with significant co-morbid medical conditions that would prevent the patient from completing treatment on this protocol, per Investigator discretion.
Patients desiring future fertility.
Sites / Locations
- James LiljaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
Ovarian peritoneal
Appendix Psuedomyxoma
Gastric and Pancreato-biliary
Mesothelioma and Sarcoma
CDDP Cisplatin 75 mg/m2 @T0 Ovarian peritoneal fallopian tube Uterine
MMC Mitomycin 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0 Appendix Psuedomyxoma colorectal small bowel
MMC Mitomycin + CDDP Cisplatin 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0
CDDP Cisplatin + Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0