Minimally-Invasive Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy in Treating Patients with Low-Volume Peritoneal Carcinomatosis
Inclusion Criteria
- Capable of providing informed consent
- Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or primary mesothelioma, with no systemic metastases
- Evidence of low-volume peritoneal disease defined by a peritoneal carcinomatosis index (PCI) =< 10 based on cross-sectional imaging and/or diagnostic laparoscopy findings
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2
- Patients who are medically fit for surgery defined as the following
- No parenchymal hepatic metastases
- No cross sectional imaging findings indicative of multi-segmental (> 1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity
- No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis
- Absolute neutrophil count (ANC) > 1500/mm^3
- White blood cell count (WBC) > 4000/mm^3
- Platelet count > 150,000/mm^3
- An international normalized ratio (INR) =< 1.5 (patients who are therapeutically anticoagulated for unrelated medical conditions such as atrial fibrillation and whose antithrombotic treatment can be withheld for operation will be eligible)
- Total serum bilirubin =< 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert’s syndrome)
- Alkaline phosphatase < 3 times the upper limit of normal (alkaline phosphatase and aspartate aminotransferase [AST] cannot both exceed the upper limit of normal)
- AST < 3 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal)
- Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine within normal limits
- Creatinine within normal limits
- Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery)
- No clinical history of acute myocardial infarction within six months of registration
- Patients who are status post revascularization procedures with satisfactory cardiac function are eligible
- No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease
- No concurrent second malignancy requiring systemic therapy
- No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements
Exclusion Criteria
- Peritoneal carcinomatosis index (PCI) >= 10
- Systemic (extraperitoneal) disease, pregnant, incarcerated
- Pregnant and lactating women; women of reproductive age must be willing to use contraception during study therapy
California
Encinitas
La Jolla
San Diego
Vista
PRIMARY OBJECTIVES:
I. To measure the rate of postoperative complications occurring within 30 days of surgery.
SECONDARY OBJECTIVES:
I. Measure completeness of cytoreduction.
II. Determine time to return of bowel function.
III. Measure length of hospital, and length of intensive-care unit (ICU) stay.
IV. Record post-operative intravenous (IV) narcotic requirements.
V. Determine recurrence free and disease-specific survival.
OUTLINE:
Patients undergo minimally-invasive cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) comprising mitomycin C (primary appendiceal and colorectal cancers); and cisplatin or doxorubicin hydrochloride (primary peritoneal mesothelioma or ovarian primary tumors).
After completion of study treatment, patients are followed up at 2 and 6 weeks, every 3-6 months for 1 year, every 6 months for 2 years, and then yearly for up to 3 years.
Trial Phase Phase I
Trial Type Treatment
Lead Organization
University of California San Diego
Principal Investigator
Kaitlyn Kelly
- Primary ID 131071
- Secondary IDs NCI-2014-02176
- Clinicaltrials.gov ID NCT02463877