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

Phase 2

Recruiting

• Conditions: Metastatic Pancreatic Carcinoma; Stage IV Pancreatic Cancer AJCC V8; Metastatic Malignant Neoplasm in the Peritoneum
• Interventions: Drug: Cisplatin; Drug: Hyperthermic Intraperitoneal Chemotherapy; Drug: Nab-paclitaxel; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

• Registration Number: NCT04858009
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate overall survival 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 assess morbidity for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy.

OUTLINE:

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 computed tomography (CT) scan, magnetic resonance imaging (MRI) or positron emission tomography (PET) during screening.

After completion of study treatment, patients are followed up every 6 months.

Study Timeline

• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-23
• Study Start: 2024-02-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (HIPEC)	Hyperthermic Intraperitoneal Chemotherapy	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.
Treatment (HIPEC)	Computed Tomography	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.
Treatment (HIPEC)	Magnetic Resonance Imaging	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.
Treatment (HIPEC)	Positron Emission Tomography	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.
Treatment (HIPEC)	Nab-paclitaxel	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.
Treatment (HIPEC)	Cisplatin	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	Up to 4 years	Overall survival will be assessed from the date of cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) to death by any cause, regardless of disease recurrence. Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient may be contacted by telephone and/or videoconferencing.
Progression-free survival	Up to 4 years	Progression-free survival is will be assessed from the date of cytoreduction and HIPEC to recurrence of tumor or death. Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient may be contacted by telephone and/or videoconferencing.

Secondary Outcome Measures

Name	Time	Method
Morbidity	30 days; up to 4 years	Morbidity is the state of having a specific illness or condition. Morbidity will be measured based on hospital length of stay, readmission rate, reoperation rate, and 30-day mortality (death).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States