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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cisplatin

    Drug

    Given via HIPEC

  • Hyperthermic Intraperitoneal Chemotherapy

    Drug

    Undergo HIPEC with mitomycin and cisplatin

  • Nab-paclitaxel

    Drug

    Given via HIPEC

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Treatment (HIPEC)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 4 years
2

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.

Time frame
Up to 4 years

Secondary outcomes

1

Morbidity

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).

Time frame
30 days; up to 4 years

Other outcomes

Sponsors and contacts

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