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

Study Overview
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Brief Summary
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This phase II trial studies the effects of hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with pancreatic cancer that has spread to the internal abdominal area (peritoneal metastasis). Chemotherapy drugs, such as nab-paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC involves heated chemotherapy that is placed directly in the abdomen through laparoscopic instruments, instead of through an intravenous injection. This study may help doctors determine how safe and effective HIPEC work in treating patient with pancreatic cancer.

Detailed Description
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PRIMARY OBJECTIVE: I. To assess short-term morbidity and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy. SECONDARY OBJECTIVE: I. To evaluate the efficacy of a polymerase chain reaction (PCR)-based quantitative cell-free deoxyribonucleic acid (DNA) KRAS mutation assay in identifying patients at risk of peritoneal recurrence/progression. OUTLINE: Patients undergo HIPEC with nab-paclitaxel and cisplatin over 60 minutes in the absence of disease progression or unacceptable toxicity. Patients may undergo additional HIPEC with paclitaxel and cisplatin up to 5 times. After completion of study treatment, patients are followed up every 6 months.

Official Title
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A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis

Conditions
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Metastatic Pancreatic Carcinoma, Stage IV Pancreatic Cancer AJCC v8

Intervention / Treatment
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* Drug: Cisplatin
* Drug: Hyperthermic Intraperitoneal Chemotherapy
* Drug: Nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (HIPEC)<br>Patients undergo HIPEC with nab-paclitaxel and cisplatin over 60 minutes in the absence of disease progression or unacceptable toxicity. Patients may undergo additional HIPEC with paclitaxel and cisplatin up to 5 times. | Drug: Cisplatin<br>* Given via HIPEC<br>* Other names: Platosin;Drug: Hyperthermic Intraperitoneal Chemotherapy<br>* Undergo HIPEC with mitomycin and cisplatin<br>* Other names: HIPEC;Drug: Nab-paclitaxel<br>* Given via HIPEC<br>* Other names: Protein-bound Paclitaxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Will be estimated using the Kaplan-Meier method. | Up to 4 years | 
| Disease free survival |  | Up to 4 years | 
| Peritoneal-free recurrence |  | Up to 4 years | 
| Morbidity |  | Up to 30 days | 
| Mortality |  | Up to 30 days | 
| Hospital length of stay |  | Up to 4 years | 
| Pancreatic fistula rate |  | Up to 4 years | 
| EBL |  | Up to 4 years | 
| Operative time |  | Up to 4 years |