Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis

Launched by MAYO CLINIC · Apr 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called hyperthermic intraperitoneal chemotherapy (HIPEC) for patients with pancreatic cancer that has spread to the abdominal area. HIPEC uses heated chemotherapy drugs, such as nab-paclitaxel and cisplatin, which are delivered directly into the abdomen to help stop the growth of cancer cells. This trial aims to find out how safe and effective this method is for patients with metastatic pancreatic cancer, which is a more advanced stage of the disease.

To participate in this trial, patients need to be between 18 and 80 years old and have a specific type of pancreatic cancer that can be confirmed through medical tests. They should also have completed some initial chemotherapy and show signs of improvement in their condition. Participants will receive the HIPEC treatment and will be monitored closely for any side effects and how well the treatment works. It’s important to know that certain patients, like those with cancer that has spread beyond the abdomen or those who are pregnant, may not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>= 18 but =\< 80
• • Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• • Cytologic or histologic proof of adenocarcinoma of the pancreas
• • Leukocytes \>= 3,000/uL
• • Absolute neutrophil count \>= 1,500/uL
• • Platelets \>= 60,000/Ul
• • Serum creatinine =\< 1.5 mg/dL
• * Distant metastatic disease of peritoneum may be visualized on imaging:
• • Positive peritoneal cytology
• • Limited carcinomatosis on diagnostic laparoscopy or laparotomy
• • KRASD assay positive peritoneal washings/cytology
• • Completion of preoperative systemic chemotherapy with biochemical, metabolic, and/or radiographic response defined as a reduction in the baseline CA 19-9 by \> 50% or radiographic response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or metabolic response on positron emission tomography (PET)-magnetic resonance imaging (MRI) defined by PET Response Criteria in Solid Tumors (PERCIST) criteria
• • Peritoneal Carcinomatosis Index (PCI) =\< 7 and surgeons deems high likelihood for a complete cytoreduction
• Exclusion Criteria:
• * Distant metastatic disease not limited to peritoneum:
• • Solid organ metastases (liver, central nervous system, lung)
• • Infections such as pneumonia or wound infections that would preclude protocol therapy
• • Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
• • Subjects deemed unable to comply with study and/or follow-up procedures
• • Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity