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NCT Number: NCT04779554

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

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.

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Adenocarcinoma Adenocarcinoma, Mucinous Appendiceal Neoplasms Carcinoma Cecal Diseases Cecal Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Glandular and Epithelial Peritoneal Diseases Peritoneal Neoplasms Pseudomyxoma Peritonei Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Kentucky, Lexington, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Area Under the Curve (AUC) - Pharmacokinetics

    Time frame: Approximately 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.

  2. Drug Clearance (CL) - Pharmacokinetics

    Time frame: Approximately 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.

  3. Drug Half-Life (T1/2) - Pharmacokinetics

    Time frame: Approximately 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Prakash Pandalai, MD

CONTACT

[email protected]

859-323-8920

Sponsors and collaborators

Lead sponsor

Prakash Pandalai

Other

Registry information

Official study title

A Randomized Phase 2 Trial of Flat Dose vs. Weight-based Dose of Intra-peritoneal (IP) Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy (CRS/HIPEC) for Advanced Gastrointestinal Malignancy

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2021
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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