← Back to Search

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
Distant metastatic disease of peritoneum may be visualized on imaging: Positive peritoneal cytology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study 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.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.
Select...
My cancer has spread to the lining of my abdomen and tests confirm it.
Select...
My cancer spread is limited, confirmed by a surgical exam.
Select...
My cancer markers or scans improved after chemotherapy.
Select...
I am between 18 and 80 years old.
Select...
My surgeon believes all visible cancer can likely be removed, and my PCI score is 7 or less.
Select...
My diagnosis is pancreatic adenocarcinoma.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Progression-free survival
Secondary outcome measures
Morbidity

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
~1940
Positron Emission Tomography
2008
Completed Phase 2
~2260
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Hyperthermic Intraperitoneal Chemotherapy
2010
Completed Phase 3
~210
Nab-paclitaxel
2014
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,190 Previous Clinical Trials
3,759,061 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,795 Total Patients Enrolled
Travis E. Grotz, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
15 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the standard reason that patients receive Hyperthermic Intraperitoneal Chemotherapy?

"lg-utuc, head and neck carcinoma, and cervical cancers can all be treated with Hyperthermic Intraperitoneal Chemotherapy."

Answered by AI

What is the official stance of the FDA on Hyperthermic Intraperitoneal Chemotherapy?

"While there is some data supporting the safety of Hyperthermic Intraperitoneal Chemotherapy, it only received a score of 2 because there is no clinical evidence yet demonstrating its efficacy."

Answered by AI

Are there any past case studies of Hyperthermic Intraperitoneal Chemotherapy?

"There are presently 804 studies underway studying Hyperthermic Intraperitoneal Chemotherapy. Of these, 308 are live clinical trials in Phase 3. Not limited to one city, 45246 locations around the world are running studies for this treatment; though many of the investigations into Hyperthermic Intraperitoneal Chemotherapy originate from Shanghai, China."

Answered by AI

Are there any current openings for participants in this research?

"The clinical trial is not presently looking for participants. The study was first posted on 10/15/2022 and was last updated on 8/3/2022. While this study is not recruiting candidates at this time, there are 1404 other studies that are."

Answered by AI

Are there any inclusion or exclusion criteria for potential participants of this research?

"This study is looking for 40 individuals that have stage iv pancreatic cancer ajcc v8 and are between 18-80 years old. The most crucial inclusion criteria are as follows: 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,"

Answered by AI

Will this research allow elderly participants?

"According to the eligibility requirements listed, individuals between 18-80 years old are qualified to apply for this clinical trial. There are 87 trials available for minors and 1346 studies seeking senior participants."

Answered by AI

What is the projected participant pool for this research?

"This study is no longer recruiting patients for the trial. The clinical trial was originally posted on 10/15/2022 and was most recently edited on 8/3/2022. However, there are currently 600 other clinical trials actively enrolling patients with stage iv pancreatic cancer ajcc v8 and 804 studies for Hyperthermic Intraperitoneal Chemotherapy that participants can explore."

Answered by AI
~27 spots leftby May 2025