This phase II trial studies whether flat dose or weight-based dose of mitomycin works better during cytoreductive surgery in treating patients with gastrointestinal malignancy that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Mitomycin is a kind of antibiotics that may help block the formation of growths that may become cancer. Surgery combined with hyperthermic intraperitoneal chemotherapy is an aggressive treatment that can be very effective. Hyperthermic intraperitoneal chemotherapy is a process in which heated chemotherapy is pumped directly into the abdomen during surgery. Currently patients who undergo cytoreductive surgery receive a set dose or “flat-dose” of mitomycin. Flat dose means that everyone gets the same amount of drug. Weight-based dosage means that patient’s dose is based on body mass index which is determined by height and weight. Giving a weight-based mitomycin dose may work better and be safer than giving a flat dose mitomycin.
Additional locations may be listed on ClinicalTrials.gov for NCT04779554.
Locations matching your search criteria
United States
Kentucky
Lexington
University of Kentucky/Markey Cancer CenterStatus: Active
Contact: Prakash K. Pandalai
Phone: 240-330-9506
PRIMARY OBJECTIVE:
I. To assess and compare area under the curve (AUC)s of two dosing strategies (flat and weight-based) for intra-peritoneal administration of heated mitomycin (mitomycin C) in cytoreductive surgery (cytoreductive surgery [CRS]/heated intra-peritoneal chemotherapy [HIPEC]) for peritoneal carcinomatosis.
SECONDARY OBJECTIVES:
I. To evaluate and compare the safety and toxicity profiles of two dosing strategies for intra-peritoneal administration of heated mitomycin C, specifically the incidence of neutropenia, acute renal dysfunction and post-operative complications.
II. To determine the correlation of peritoneal fluid maximum of concentration (Cmax) of mitomycin C with plasma blood levels using pharmacokinetic analysis and examine associations to adverse events.
III. To develop a population model for the pharmacokinetics of hyperthermic intra-peritoneal administration of mitomycin C.
CORRELATIVES AND EXPLORATORY OBJECTIVES:
I. To assess the associations of post-surgical complications (30-day, 60-day and 90-day) with differences in pharmacokinetic (PK) parameters (plasma and peritoneal concentrations observed) by receipt of weight-based dosing versus flat dosing of mitomycin C.
II. To analyze tumor concentrations of mitomycin C pre-HIPEC and post-HIPEC.
III. To describe intra-individual and aggregate changes in key patient-reported outcomes assessing quality of life.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: During standard of care CRS, patients receive flat dose of mitomycin intraperitoneally (IP) over 5 minutes via HIPEC at minutes 0 and 45 on day 1 (day of surgery).
ARM II: During standard of care CRS, patients receive weight-based dose of mitomycin IP over 5 minutes via HIPEC at minutes 0 and 45 on day 1 (day of surgery).
All patients also undergo collection of blood and peritoneal fluid samples as well as standard of care computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) throughout the study.
After completion of study treatment, patients are followed up at 30, 60, and 90 days, and then every 3-6 months for up to 1 year.
Lead OrganizationUniversity of Kentucky/Markey Cancer Center
Principal InvestigatorPrakash K. Pandalai