Heated chemotherapy for pancreatic cancer with peritoneal metastasis
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis
This study is testing if heated chemotherapy delivered directly into the abdomen can help people with pancreatic cancer that has spread to the lining of the belly live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04858009 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with pancreatic cancer that has spread to the peritoneum. The approach involves administering heated chemotherapy drugs, such as nab-paclitaxel and cisplatin, directly into the abdominal cavity through laparoscopic techniques. The study aims to assess overall survival and disease-free survival outcomes, as well as the safety and morbidity associated with this treatment. Patients will be monitored through imaging techniques and followed up every six months after treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with confirmed pancreatic adenocarcinoma and limited peritoneal metastasis.
Not a fit: Patients with extensive peritoneal carcinomatosis or those who do not respond to preoperative chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced pancreatic cancer.
How similar studies have performed: Previous studies have shown promising results with HIPEC in other cancers, but its application in pancreatic cancer is still being explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Cornelius A. Thiels, DO, MBA — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.