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Comparing Mitomycin C Dosing for Peritoneal Carcinomatosis

This study is looking at two different ways to give Mitomycin C (a chemotherapy drug) during heated intraperitoneal chemotherapy (HIPEC) for people with peritoneal carcinomatosis (cancer spread to the lining of the abdomen). Researchers want to see if giving a "flat dose" (the same amount for everyone) of Mitomycin C works differently than a "weight-based dose" (an amount adjusted for your body size). The study will measure how the body absorbs and processes the drug (pharmacokinetics) to understand which dosing method is better. You may be able to join if you are 18 or older, have certain types of peritoneal carcinomatosis, are healthy enough for surgery, and have a life expectancy greater than 3 months. The study aims to enroll 100 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 100 participants to compare two different dosing methods of Mitomycin C.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, which measure how your body processes the drug, will be assessed at approximately 20 hours after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04779554

Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC

Recruiting
PHASE2Ages 18+InterventionalTreatment
Prakash Pandalai
~100 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Mitomycin C, flat dose 40 mgMitomycin C, weight-based dose 12.5 mg/m2

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area Under the Curve (AUC) - Pharmacokinetics
Measured over Approximately 20 hours
+2 more outcomes measured

Conditions

Peritoneal Carcinomatosis

Explore related trials

Appendiceal mucinous neoplasmAppendix CarcinomaColorectal CarcinomaPeritoneal CarcinomatosisPseudomyxoma Peritonei

Where it's being run

2 sites across 2 states
Kentucky1
Vermont1

Study leadership

  • Prakash Pandalai, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Prakash Pandalai, MD
[email protected]
859-323-8920
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Eligibility criteria

Inclusion

Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, pseudomyxoma peritonei, appendiceal cancer with peritoneal carcinomatosis, colorectal cancer with peritoneal carcinomatosis
ECOG performance status \< 3
Candidate for grossly complete cytoreductive surgery
Life expectancy greater than 3 months
Adequate organ and marrow function
Ability to understand and the willingness to sign a written informed consent document

Exclusion

Any extra-abdominal metastases
Untreated lung metastases
Liver metastases not amenable to resection or ablation
Known brain metastases
Chemotherapy or radiotherapy within 4 weeks prior to entering the study
Presence of residual significant adverse events attributed to prior cancer treatment
Currently receiving any other investigational therapeutic agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mitomycin C.
Pregnant or breast-feeding women
Uncontrolled ongoing illness

What this trial measures

  • Area Under the Curve (AUC) - PharmacokineticsApproximately 20 hours

    Drug exposure will be measured by calculating the area under the curve (AUC) or integral of a plasma concentration-time curve. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.

  • Drug Clearance (CL) - PharmacokineticsApproximately 20 hours

    Drug clearance will be calculated as the volume of plasma cleared per unit time. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.

  • Drug Half-Life (T1/2) - PharmacokineticsApproximately 20 hours

    Drug half-life will be calculated as the time required for the plasma Mitomycin C concentration to be half of its maximum concentration. Samples will be collected at 0,15, 30, 60 and 90 minutes intra-operatively, and 2, 4, and 12 hours postoperatively.