Recruiting
Phase 2

HIPEC with Mitomycin C

Sponsor:

Prakash Pandalai

Code:

NCT04779554

Conditions

Peritoneal Carcinomatosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mitomycin C, flat dose 40 mg

Mitomycin C, weight-based dose 12.5 mg/m2

Study Details

Brief summary:

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.

Conditions

Peritoneal Carcinomatosis

Study ID

NCT04779554

Start date

Jun 4, 2021

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Flat Dose Mitomycin C

Participants in this group will receive flat doses of mitomycin C intra-operatively: 1) 30mg at minute 0 and 2) 10mg at minute 45. Mitomycin C will be delivered via HIPEC (hyperthermic intraperitoneal chemotherapy).

experimental: Weight-Based Mitomycin C

Participants in this group will receive weight-based dosing of mitomycin C intra-operatively: 1) 9.5 mg/m2 at minute 0 and 2) 3 mg/m2 at minute 45 for total dose of 12.5 mg/m2. Mitomycin C will be delivered via HIPEC (hyperthermic intraperitoneal chemotherapy).

Interventions

Mitomycin C, flat dose 40 mg

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

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.

Primary outcome measure

  • Area Under the Curve (AUC) - Pharmacokinetics [ Time Frame: Approximately 20 hours ]
  • Drug Clearance (CL) - Pharmacokinetics [ Time Frame: Approximately 20 hours ]
  • Drug Half-Life (T1/2) - Pharmacokinetics [ Time Frame: Approximately 20 hours ]

Central Contacts and Locations

Central contacts

Prakash Pandalai, MD

859-323-8920Prakash.Pandalai@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Prakash Pandalai, MD

Prakash.Pandalai@uky.edu

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Jessica Cintolo-Gonzalez

802-847-2262jessica.cintolo-gonzalez@uvmhealth.org

More Information

Sponsor

Prakash Pandalai

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • cytoreductive surgery
  • colorectal cancer
  • pseudomyxoma peritonei
  • appendiceal mucinous neoplasm
  • mitomycin C
  • pharmacokinetics
  • CRS/HIPEC
  • HIPEC
  • Appendix cancer
  • LAMN

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Prakash Pandalai on 2026-04-01.