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Anti-tumor antibiotic
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area Under the Curve (AUC) - Pharmacokinetics
Drug Clearance (CL) - Pharmacokinetics
Drug Half-Life (T1/2) - Pharmacokinetics
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).
Find a Location
Who is running the clinical trial?
Prakash PandalaiLead Sponsor
Prakash Pandalai, MDPrincipal Investigator - University of Kentucky
University of Kentucky Albert B. Chandler Hospital
Wright State University School Of Medicine (Medical School)
University Hosp, Inc (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to drugs similar to Mitomycin C.You are a suitable candidate for a surgery that aims to remove as much of the tumor as possible.You have cancer that has spread to your brain.You have received chemotherapy or radiotherapy within the past 4 weeks.You still have side effects from previous cancer treatments that are causing problems.You are currently taking any experimental medications.You have a medical condition that is not being well managed or controlled.Your organs and bone marrow are functioning properly.
Research Study Groups:
This trial has the following groups:- Group 1: Flat Dose Mitomycin C
- Group 2: Weight-Based Mitomycin C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Mitomycin C, with a weight-based dose of 12.5 mg/m2, safe for human use?
"Our assessment of the safety profile of Mitomycin C, weight-based dose 12.5 mg/m2 is a 2 as there have been studies conducted to assess its safety yet efficacy has not been investigated in this context."
Answered by AI
Is enrollment still open for this experiment?
"Affirmative. Clinicaltrials.gov reveals that the research first opened its recruitment on February 28th 2021 and was last updated March 1st 2022, with 100 patients being sought from a single location."
Answered by AI
Has there been any past research examining the efficacy of a 12.5 mg/m2 Mitomycin C dosage based on body weight?
"Presently, 40 clinical trials of Mitomycin C weight-based dose 12.5 mg/m2 are underway with 10 in Phase 3. With the majority occurring at a singular site in Bethesda, MD; however, over 2000 locations across the globe are running tests to investigate this medication's effects."
Answered by AI
How many participants have been inducted into this study?
"Affirmative. According to clinicaltrials.gov, this medical research project - first listed on February 28th 2021- is in the process of recruiting participants. 100 volunteers must be sourced from a single trial site."
Answered by AI
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