Chemotherapy Dosing Strategies for Peritoneal Carcinomatosis

Phase 2

Recruiting

Led By Prakash Pandalai, MD

Research Sponsored by Prakash Pandalai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 20 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether weight-based or flat dosing of a chemotherapy drug is more effective in treating peritoneal carcinomatosis.

Who is the study for?

This trial is for patients with specific abdominal cancers (like appendiceal cancer or colorectal cancer that has spread to the lining of the abdomen) who are fit enough for surgery and have a life expectancy over 3 months. They must understand and agree to the study's terms, have good organ function, and not be pregnant or breastfeeding. People with metastases outside the abdomen, recent chemotherapy or radiotherapy, ongoing severe illness, or allergies to similar drugs cannot join.

What is being tested?

The study is testing two ways of giving Mitomycin C during heated chemo after tumor-removing surgery: one based on patient weight (12.5 mg/m2) and another as a flat dose (40 mg). The goal is to see if weight-based dosing can effectively target peritoneal surfaces while reducing overall toxicity compared to flat dosing.

What are the potential side effects?

Mitomycin C may cause side effects such as damage to blood cells leading to increased infection risk, fatigue, kidney problems, lung issues like trouble breathing or coughing. There might also be allergic reactions in those sensitive to its components.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 20 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 20 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 20 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area Under the Curve (AUC) - Pharmacokinetics

Drug Clearance (CL) - Pharmacokinetics

Drug Half-Life (T1/2) - Pharmacokinetics

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Weight-Based Mitomycin CExperimental Treatment1 Intervention

Participants in this group will receive weight-based dosing of mitomycin C intra-operatively: 1) 9 mg/m2 at minute 0 and 2) 3.5 mg/m2 at minute 60 for total dose of 12.5 mg/m2. Mitomycin C will be delivered via HIPEC (hyperthermic intraperitoneal chemotherapy).

Group II: Flat Dose Mitomycin CExperimental Treatment1 Intervention

Participants in this group will receive flat doses of mitomycin C intra-operatively: 1) 30mg at minute 0 and 2) 10mg at minute 60. Mitomycin C will be delivered via HIPEC (hyperthermic intraperitoneal chemotherapy).

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