← Back to Search

Platinum-containing Compound

Heated Chemotherapy for Metastatic Pancreatic Cancer

Rochester, MN
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.

See full description
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.Check my eligibility
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.See study design
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
Select...
My test for KRAS mutation in abdominal fluid is positive.
 show original
Select...
My cancer spread is limited, confirmed by a surgical exam.
 show original
Select...
My cancer markers or scans improved after chemotherapy.
 show original
Select...
I am between 18 and 80 years old.
 show original
Select...
My diagnosis is pancreatic adenocarcinoma.
 show original
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
 show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to organs like the liver, brain, or lungs.
 show original
Select...
I do not have infections like pneumonia that would stop me from following the treatment plan.
 show original
Select...
I've had a severe allergic reaction to chemotherapy before.
 show original

Timeline

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
5%
Grade IV
5%
Grade I
100%
80%
60%
40%
20%
0%
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
~3040
Hyperthermic Intraperitoneal Chemotherapy
2010
Completed Phase 3
~210
Computed Tomography
2017
Completed Phase 2
~2440
Magnetic Resonance Imaging
2020
Completed Phase 3
~1180
Positron Emission Tomography
2011
Completed Phase 2
~2230
Nab-paclitaxel
2014
Completed Phase 3
~2490

Find a Location

Closest Location:Mayo Clinic in Rochester· Rochester, MN· 565 miles

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,413 Previous Clinical Trials
3,208,783 Total Patients Enrolled
National Cancer Institute (NCI)NIH
14,057 Previous Clinical Trials
41,149,393 Total Patients Enrolled
Travis E. Grotz, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
15 Total Patients Enrolled
Cornelius A. Thiels, D.O., M.B.A.Principal InvestigatorMayo Clinic in Rochester
Cornelius A. Thiels, DO, MBAPrincipal InvestigatorMayo Clinic in Rochester
Travis E GrotzPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Cisplatin (Platinum-containing Compound) Clinical Trial Eligibility Overview. Trial Name: NCT04858009 — Phase 2
Peritoneal Cancer Research Study Groups: Treatment (HIPEC)
Peritoneal Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04858009 — Phase 2
Cisplatin (Platinum-containing Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04858009 — Phase 2
~20 spots leftby May 2026