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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Prakash Pandalai
Study ID
NCT04779554
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Peritoneal Carcinomatosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 4, 2021
Status verified
Mar 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

Area Under the Curve (AUC) - Pharmacokinetics [ Time Frame: Approximately 20 hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Prakash Pandalai, MD
[email protected]
University of Vermont Medical CenterBurlingtonVermont05401
Jessica Cintolo-Gonzalez
[email protected]
802-847-2262

Find similar trials in Lexington, KY

By research site
University of Kentucky· Lexington, KYUniversity of Vermont Medical Center· Burlington, VT

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