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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04858009
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 43.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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 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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Pancreatic Carcinoma; Stage IV Pancreatic Cancer AJCC v8	Drug: Cisplatin; Drug: Hyperthermic Intraperitoneal Chemotherapy; Drug: Paclitaxel	Phase 2

Detailed Description

PRIMARY OBJECTIVE:

1. To assess short-term morbidity and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy.

SECONDARY OBJECTIVE:

1. To evaluate the efficacy of a polymerase chain reaction (PCR)-based quantitative cell-free deoxyribonucleic acid (DNA) KRAS mutation assay in identifying patients at risk of peritoneal recurrence/progression.

OUTLINE:

Patients undergo HIPEC with paclitaxel and cisplatin over 60 minutes in the absence of disease progression or unacceptable toxicity. Patients may undergo additional HIPEC with paclitaxel and cisplatin up to 5 times.

After completion of study treatment, patients are followed up every 6 months.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis
• Anticipated Study Start Date: Oct 15, 2022
• Anticipated Primary Completion Date: May 31, 2025
• Anticipated Study Completion Date: May 31, 2026

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment (HIPEC) Patients undergo HIPEC with paclitaxel and cisplatin over 60 minutes in the absence of disease progression or unacceptable toxicity. Patients may undergo additional HIPEC with paclitaxel and cisplatin up to 5 times.

Drug: Cisplatin; Given via HIPEC; Other Names: Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin ; Drug: Hyperthermic Intraperitoneal Chemotherapy; Undergo HIPEC with mitomycin and cisplatin; Other Names: HIPEC ; Drug: Paclitaxel; Given via HIPEC; Other Names: Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat

Outcome Measures

Primary Outcome Measures

1. Overall survival [Up to 4 years]

   Will be estimated using the Kaplan-Meier method.

2. Disease free survival [Up to 4 years]

3. Peritoneal-free recurrence [Up to 4 years]

4. Morbidity [Up to 30 days]

5. Mortality [Up to 30 days]

6. Hospital length of stay [Up to 4 years]

7. Pancreatic fistula rate [Up to 4 years]

8. EBL [Up to 4 years]

9. Operative time [Up to 4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

• Distant metastatic disease of peritoneum may be visualized on imaging:

• Positive peritoneal cytology

• Limited carcinomatosis on diagnostic laparoscopy or laparotomy

• KRASD assay positive peritoneal washings/cytology

• Completion of preoperative systemic chemotherapy with biochemical, metabolic, and/or radiographic response defined as a reduction in the baseline CA 19-9 by > 50% or radiographic response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or metabolic response on positron emission tomography (PET)-magnetic resonance imaging (MRI) defined by PET Response Criteria in Solid Tumors (PERCIST) criteria

• Peritoneal Carcinomatosis Index (PCI) =< 7 and surgeons deems high likelihood for a complete cytoreduction

Exclusion Criteria:

• 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

• 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

• Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Travis E Grotz, Mayo Clinic in Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04858009
• Other Study ID Numbers: 18-009451; NCI-2021-02990; 18-009451; P30CA015083
• First Posted: Apr 23, 2021
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms; Paclitaxel; Cisplatin; Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Aug 4, 2022