The goal of this clinical trial is to learn if paricalcitol or pirfenidone can help make tumors removable by surgery in adults with peritoneal cancer who are currently unable to have their tumor removed.
The study aims to answer are whether paricalcitol or pirfenidone improve tumor response and tissue healing after 12 weeks of treatment, and which of these two drugs is more effective at helping participants become eligible for surgery. Researchers will compare paricalcitol to pirfenidone to see which drug works better and has a manageable safety profile.
Participants will take either paricalcitol or pirfenidone by mouth every day for 12 weeks while continuing their standard chemotherapy, visit the clinic regularly for checkups and lab tests, keep a daily diary to track their study medication, and undergo a surgical re-evaluation after treatment to see if their tumor can be removed.
Males or females, age 18 to <81 years at the time of consent
Biopsy-proven peritoneal carcinomatosis
Documented receipt of at least three months of standard systemic chemotherapy prior to initiation, with persistent disease
ECOG Performance Status of 0 or 1
Patients deemed eligible for definitive cytoreductive surgery
Current or recent (within 30 days) use of paricalcitol, pirfenidone, or Vitamin D supplementation above USDA-recommended daily dosage
Known allergy or medical contraindication to study drugs
Hypersensitivity to any of the study drugs or to any ingredient in the formulation
Parallel
Paricalcitol
DrugOral, 2 mcg once daily for 12 weeks
pirfenidone
DrugOral, titrated up to 801 mg three times daily (total daily dose: 2403 mg/day) with food for 12 weeks.
Paricalcitol Efficacy
Proportion of patients achieving a clinicopathologic response (CPR)
Pirfenidone Efficacy
Proportion of patients achieving a clinicopathologic response (CPR)
Severity of Treatment-Emergent Adverse Events for Paricalcitol [Safety]
Maximum severity grade of treatment-emergent adverse events per participant, assessed on a scale from Grade 1 (mild) to Grade 5 (death) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Higher grades indicate a more severe outcome.
Severity of Treatment-Emergent Adverse Events for Pirfenidone [Safety]
Maximum severity grade of treatment-emergent adverse events per participant, assessed on a scale from Grade 1 (mild) to Grade 5 (death) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Higher grades indicate a more severe outcome
Incidence of Treatment-Emergent Adverse Events for Paricalcitol [Safety
Number of participants experiencing one or more treatment-emergent adverse events, as graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Incidence of Treatment-Emergent Adverse Events for Pirfenidone [Safety]
Number of participants experiencing one or more treatment-emergent adverse events, as graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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Patrick Wagner, MD, FACS
Lead sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
