NCT04858009

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
37mo left

Started Feb 2024

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Feb 2024Jul 2029

First Submitted

Initial submission to the registry

April 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
2.8 years until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

5.4 years

First QC Date

April 14, 2021

Last Update Submit

December 10, 2025

Conditions

Metastatic Pancreatic CarcinomaStage IV Pancreatic Cancer AJCC v8Metastatic Malignant Neoplasm in the Peritoneum

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    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.

    Up to 4 years

  • Progression-free survival

    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.

    Up to 4 years

Secondary Outcomes (1)

  • Morbidity

    30 days; up to 4 years

Study Arms (1)

Treatment (HIPEC)

EXPERIMENTAL

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.

Drug: CisplatinDrug: Hyperthermic Intraperitoneal ChemotherapyDrug: Nab-paclitaxelProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Interventions

Hyperthermic Intraperitoneal ChemotherapyDRUG

Undergo HIPEC with mitomycin and cisplatin

Also known as: HIPEC
Treatment (HIPEC)
Nab-paclitaxelDRUG

Given via HIPEC

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Paclitaxel nanoparticle albumin-bound, Protein-bound Paclitaxel
Treatment (HIPEC)
Computed TomographyPROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography, Computerized Tomography, CT, CT Scan
Treatment (HIPEC)
Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, Nuclear magnetic resonance imaging (NMRI), Structural MRI (sMRI)
Treatment (HIPEC)
Positron Emission TomographyPROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan, proton magnetic resonance spectroscopic imaging, PT
Treatment (HIPEC)
CisplatinDRUG

Given via HIPEC

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Treatment (HIPEC)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

  • Gudmundsdottir H, Yonkus JA, Thiels CA, Warner SG, Cleary SP, Kendrick ML, Truty MJ, Grotz TE. Oncologic Outcomes of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Highly Selected Patients with Metastatic Pancreatic Ductal Adenocarcinoma. Ann Surg Oncol. 2023 Nov;30(12):7833-7839. doi: 10.1245/s10434-023-14138-3. Epub 2023 Aug 19.

    PMID: 37596449DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cisplatin1,2-diaminocyclohexaneplatinum II citratePlatinumHyperthermic Intraperitoneal Chemotherapy130-nm albumin-bound paclitaxelAlbumin-Bound PaclitaxelTaxesMagnetic Resonance SpectroscopyX-Rays

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsMetals, HeavyElementsTransition ElementsMetalsChemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, InducedPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsEconomicsHealth Care Economics and OrganizationsSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Cornelius A. Thiels, DO, MBA

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2021

First Posted

April 23, 2021

Study Start

February 15, 2024

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations

US(1)