Comparing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC) Using Mitomycin-C Versus Melphalan for Colorectal Peritoneal Carcinomatosis

NCT03073694 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: IIT-2016-MAGIMelphVMitCHIPEC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to compare the morbidity and mortality of CRS-HIPEC using mitomycin-C versus melphalan for colorectal peritoneal carcinomatosis. Morbidity and mortality will measured using the Comprehensive Complication Index (CCI) score, Common terminology criteria for adverse events (CTCAE version 4.03), and the Clavien-Dindo Classification.

Conditions

Cancer, Appendiceal; ColoRectal Cancer

Keywords

Peritoneal Surface Disease; mitomycin-c; melphalan; Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC); Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• Comprehensive Complication Index (CCI) score.

  CCI will be evaluated using the following data: morbidity, mortality.

  Every 3 months until Year 2

Study Arms (2)

Mitomycin C Group

ACTIVE COMPARATOR

Mitomycin-C initial dose of 15 mg/m2 (milligrams per meter squared) 45 minutes into the perfusion, a maintenance dose of 5 mg/m2 will be administered.

Drug: Mitomycin c

Melphalan Group

EXPERIMENTAL

Melphalan 60 mg/m2 (milligrams per meter squared) 45 minutes into the perfusion.

Drug: Melphalan

Interventions

Mitomycin c DRUG

Mitomycin-c will be given to participants in Treatment Arm 1 as a one-time, intraoperative, intravenous administration for a duration of 90 minutes. 45 minutes into the perfusion, a maintenance dose will be administered.

Also known as: Mutamycin, MTC

Mitomycin C Group

Melphalan DRUG

Melphalan will be given to participants in Treatment Arm 2 as a one-time, intraoperative, intravenous administration for a duration of 90 minutes.

Also known as: Alkeran

Melphalan Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent.
• Peritoneal Surface Disease (PSD) due to Colorectal Cancer or High-Grade Appendiceal Cancer
• No clear evidence of systemic metastases
• No prior CRS-HIPEC treatment
• Patient has a planned CC0 (Complete Macroscopic Cytoreduction (visual)) cytoreduction - NOTE: randomization occurs during surgery and not before; if, during surgery, the PI/SubI discerns that all disease cannot be removed surgically, the participant will be considered a "screen failure", HIPEC will not be performed, and the participant will be removed from the study. If participant is removed from the study, PI / surgeon will decide if standard of care surgery will proceed.
• Age 18 - 75
• ECOG (Eastern Cooperative Oncology Group) Score 0 - 2
• Recorded ASA (American Society of Anesthesiologist Classification) classification - as determined by the anesthesiologist (particular value not required - only recording of the classification is required).
• Medically fit to undergo complex major abdominal surgery, as determined by examination by PI / Sub-Is.
• Medically fit to receive systemic chemotherapy, as determined by examination by PI / Sub-Is.
• Adequate organ and marrow function as defined below:
• leukocytes ≥ 3,000/mcL (microliter)
• absolute neutrophil count ≥ 1,500/mcL
• platelets ≥ 100,000/mcL
• total bilirubin within normal institutional limits

You may not qualify if:

• Current or anticipated use of other investigational agents while participating in this study.
• Patient has received systemic chemotherapy or radiotherapy within 4 weeks prior to study enrollment.
• Patient has not recovered sufficiently (PI will judge patient recovery status) from adverse events due to agents administered more than 4 weeks prior to enrollment on this study.
• Patient has history of or currently has non-peritoneal surface metastatic disease in addition to peritoneal surface malignancy.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to mitomycin-C or melphalan.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life-threatening cardiac arrhythmia, severe pulmonary disease, uncontrolled diabetes, severe kidney disease or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants.
• Patient actively being treated for other malignancy (current active treatment of early stage squamous or basal cell carcinomas of the skin is allowed, excluding treatment with other investigational agents and systemic chemotherapy or radiotherapy).

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Medical Center

Westwood, Kansas, 66205, United States

RECRUITING

MeSH Terms

Conditions

Appendiceal Neoplasms; Colorectal Neoplasms; Peritoneal Neoplasms

Interventions

Mitomycin; Melphalan

Condition Hierarchy (Ancestors)

Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases; Colonic Diseases; Rectal Diseases; Abdominal Neoplasms; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mazin Al-kasspooles, MD

  The University of Kansas - Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mazin Al-kasspooles, MD

CONTACT

913-588-6568; mal-kasspooles@kumc.edu

Ashley Shores

CONTACT

913-588-1897; ashores@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: March 8, 2017
• Study Start: July 14, 2017
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)