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

ConditionPeritoneal Carcinomatosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrakash Pandalai

About this trial

Peritoneal carcinomatosis from advanced gastro-intestinal malignancy has historically been associated with poor overall survival (≤ 12 months) with few treatment options. Cytoreductive surgery (CRS), which involves removal of all macroscopic tumor nodules, combined with direct administration of heated intra-peritoneal (IP) chemotherapy (HIPEC) to the affected peritoneal surfaces, has been shown to be an effective treatment option that extends overall survival among certain cases of peritoneal carcinomatosis. IP chemotherapy allows delivery of a high dose of cytostatic drug directly onto the peritoneal surfaces at risk for microscopic residual disease while systemic exposure remains limited. Additionally, hyperthermia is known to enhance the cytotoxicity of several agents (including Mitomycin C) and improves the depth of peritoneal penetration.

This trial will be a randomized phase 2 comparison of flat dose versus weight-based dose Mitomycin C. The hypothesis of this study is that HIPEC weight-based dosing may result in similarly effective peritoneal Mitomycin C concentrations with less systemic absorption and potential systemic toxicity, compared with the HIPEC flat dosing approach in patients undergoing CRS/HIPEC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any extra-abdominal metastases

Untreated lung metastases

Liver metastases not amenable to resection or ablation

Known brain metastases

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mitomycin C, flat dose 40 mg

    Drug

    Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two flat doses. Dose 1 will be 30mg at minute 0 and dose 2 will be 10 mg at minute 45.

  • Mitomycin C, weight-based dose 12.5 mg/m2

    Drug

    Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two weight-based doses of 9.5 mg/m2 at minute 0 and 3 mg/m2 at minute 45.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Flat Dose Mitomycin CExperimental treatment 1 intervention
Group B: Weight-Based Mitomycin CExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area Under the Curve (AUC) - Pharmacokinetics

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.

Time frame
Approximately 20 hours
2

Drug Clearance (CL) - Pharmacokinetics

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.

Time frame
Approximately 20 hours
3

Drug Half-Life (T1/2) - Pharmacokinetics

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.

Time frame
Approximately 20 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prakash Pandalai

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov
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