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

Peritoneal Carcinomatosis Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779554
• Other study ID #: MCC-20-GI-115
• Status: Recruiting
• Phase: Phase 2
• Start date: June 4, 2021
• Est. completion date: February 2026

Study information

• Verified date: May 2024
• Source: University of Kentucky
• Contact: Prakash Pandalai, MD
• Phone: 859-323-8920
• Email: Prakash.Pandalai[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with one of the following: low-grade appendiceal mucinous neoplasm, 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

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prakash Pandalai

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 20 hours
Primary	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.	Approximately 20 hours
Primary	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.	Approximately 20 hours