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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.
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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 belowSelect...
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.
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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.
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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.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
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 • NCT0289144770%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My test for KRAS mutation in abdominal fluid is positive.My cancer has spread to the lining of my abdomen and tests confirm it.My cancer spread is limited, confirmed by a surgical exam.Your platelet count is at least 60,000 per microliter.My cancer markers or scans improved after chemotherapy.I am between 18 and 80 years old.My surgeon believes all visible cancer can likely be removed, and my PCI score is 7 or less.My cancer has spread to organs like the liver, brain, or lungs.I can follow the study's requirements and attend all appointments.You have enough white blood cells called neutrophils in your body.I do not have infections like pneumonia that would stop me from following the treatment plan.I am not pregnant, can avoid breastfeeding, and will use effective birth control.I've had a severe allergic reaction to chemotherapy before.My diagnosis is pancreatic adenocarcinoma.I can take care of myself and am up and about more than 50% of my waking hours.Your white blood cell count is at least 3,000 per microliter.Your blood creatinine level is not higher than 1.5 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (HIPEC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.