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

Who is this study for? Patients with Pancreatic Cancer
What treatments are being studied? Cisplatin+Hyperthermic Intraperitoneal Chemotherapy+Paclitaxel
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2029-07
Participants
Target number of participants: 40
Treatments
Experimental: Treatment (HIPEC)
Patients undergo HIPEC with nab-paclitaxel and cisplatin over 90 minutes in the absence of disease progression or unacceptable toxicity. Patients may undergo additional HIPEC with paclitaxel and cisplatin up to 5 times. Patients undergo CT scan, MRI or PET during screening.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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