A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis
Overview
- Phase
- Phase 2
- Intervention
- Cisplatin
- Conditions
- Not specified
- Sponsor
- Mayo Clinic
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Overall survival
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Cornelius A. Thiels
Principal Investigator
Mayo Clinic
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
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
Arms & Interventions
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.
Intervention: Cisplatin
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.
Intervention: Hyperthermic Intraperitoneal Chemotherapy
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.
Intervention: Nab-paclitaxel
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.
Intervention: Computed Tomography
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.
Intervention: Magnetic Resonance Imaging
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.
Intervention: Positron Emission Tomography
Outcomes
Primary Outcomes
Overall survival
Time Frame: 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
Time Frame: 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 Outcomes
- Morbidity(30 days; up to 4 years)