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Platinum-containing Compound

Heated Chemotherapy for Metastatic Pancreatic Cancer

Phase 2

Recruiting

Led By Travis E. Grotz, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

KRASD assay positive peritoneal washings/cytology

Limited carcinomatosis on diagnostic laparoscopy or laparotomy

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of chemotherapy that is heated and placed directly in the abdomen on patients with pancreatic cancer that has spread to the internal abdominal area.

Who is the study for?

This trial is for adults aged 18-80 with pancreatic cancer that has spread to the abdomen, who have responded well to prior chemotherapy. They must be in good physical condition (ECOG <=2), have a low tumor burden in the abdomen (PCI <=7), and adequate blood cell counts. Pregnant women or those unable to follow study procedures are excluded.

What is being tested?

The trial studies 'heated' chemo directly delivered into the abdomen of patients with pancreatic cancer after laparoscopic surgery. It tests how safe and effective this HIPEC method is using drugs like nab-paclitaxel and cisplatin compared to traditional intravenous methods.

What are the potential side effects?

Potential side effects include reactions related to chemotherapy such as nausea, fatigue, hair loss, nerve damage, kidney issues from cisplatin, and possible complications from abdominal surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My test for KRAS mutation in abdominal fluid is positive.

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My cancer spread is limited, confirmed by a surgical exam.

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My cancer markers or scans improved after chemotherapy.

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I am between 18 and 80 years old.

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My diagnosis is pancreatic adenocarcinoma.

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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to organs like the liver, brain, or lungs.

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I do not have infections like pneumonia that would stop me from following the treatment plan.

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I've had a severe allergic reaction to chemotherapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Progression-free survival

Secondary study objectives

Morbidity

Side effects data

From 2023 Phase 2 trial • 24 Patients • NCT02891447

70%

Grade II

30%

Grade III

Grade IV

Grade I

100%

80%

60%

40%

20%

Study treatment Arm

Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (HIPEC)Experimental Treatment6 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Positron Emission Tomography

2011

Completed Phase 2

~2200