Single Arm Study Treating Patients of Peritoneal Surface Malignancy (Colorectal, Appendical, Pseudomyxoma, Gastric) With Cytoreductive Surgery and Hyperthermic Intraperitoneal Mitomycin-C

• Status: Completed
• Trial end date: 2020-11-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical study investigating the new treatment of surgery combined with intraperitoneal mitomycin-C for patients with gastrointestinal cancer that has spread to the peritoneal (abdominal cavity) surface. Mitomycin-C to be used in this procedure is approved by the U.S. Food and Drug Administration (FDA)for many different cancers including gastrointestinal cancer. Giving mitomycin C via the intraperitoneal route is not FDA approved and is an investigation therapy. Cytoreductive surgery plus intraperitoneal chemotherapy can be offered as standard of care outside of a clinical trial. However, since this is an unproven and potentially more effective but a more toxic approach, the investigators are performing this procedure under an IRB approved clinical trial in order to better evaluate the risks and benefits of this approach.

A standardized, evidence-based approach is currently lacking for patients with peritoneal surface malignancy from gastrointestinal origin. A clinical trial with surgical quality assurance and modern hyperthermic intraperitoneal chemotherapy incorporating critical assessment of disease burden, determinants of complete cytoreduction, treatment-related toxicity, quality of life and survival is imperative. Theoretically, cytoreductive surgery is performed to treat macroscopic disease, and hyperthermic intraperitoneal chemotherapy is used to treat microscopic residual disease with the objective of removing disease completely in a single procedure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine
• Treatments: Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Capable of providing informed consent.

• The patient who has not previously received hyperthermic intraperitoneal chemotherapy must have histopathologically or cytologically confirmed cancer of colorectal, appendiceal, peritoneal mesothelioma, pseudomyxoma or gastric origin with known synchronous or metachronous disease dissemination limited to the peritoneal surfaces.

• The patient must have documented disease limited to the peritoneal surface, amenable to complete cytoreduction indicated by:

• Disease confined to the peritoneal surfaces

• No parenchymal liver metastases

• No evidence of clinical, biochemical or radiological biliary obstruction

• Small volume of disease in the gastro-hepatic ligament defined by a < 5cm mass in the epigastric region on cross-sectional imaging

• No clinical or radiological evidence of hematogenous or distant nodal metastasis

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

• Absolute neutrophil count (ANC) > 1200/mm3, white blood cell count (WBC) > 4000/mm3 and platelet count > 150,000/mm3

• 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).

• Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert's syndrome);

• alkaline phosphatase < 2.5 times the upper limit of normal; and/or

• AST < 1.5 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 are 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).

• Patients who have met the above criteria and who have undergone CRS and HIPEC in the past 18 months for the beforementioned disease processes without evidence of recurrence will be eligible for participation in this study for analyzing ability to achieve complete cytoreduction, morbidity, progression and survival.

Exclusion Criteria:

• The patients have documented disease beyond the peritoneal surfaces, which prevent achieving complete cytoreduction as indicated by:

• Evidence of distant hematogenous metastatic disease or distant nodal metastases

• Evidence of parenchymal hepatic metastases

• Evidence of clinical, biochemical or radiological biliary obstruction

• Evidence of gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity which limits ability to obtain complete cytoreduction

• 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.

• Active systemic infections, coagulation disorders, or other major medical illnesses precluding major surgery.

• Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy or radiologic studies.