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Chemotherapy +/− Surgery + Mitomycin C for Colorectal Cancer

Phase 3
Waitlist Available
Led By Alexander Stojadinovic, MD
Research Sponsored by Walter Reed Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed colon adenocarcinoma meeting the following criteria: Newly diagnosed disease, Advanced disease, Confirmed synchronous or metachronous limited peritoneal disease dissemination, Disease not appendiceal or rectal cancer, Disease not signet ring cell type, Disease amenable to complete cytoreduction surgery with specific criteria, ECOG performance status 0-1, ANC > 1,200/mm³, WBC > 4,000/mm³, Platelet count 150,000/mm³, INR ≤ 1.5, Total serum bilirubin ≤ 1.5 mg/dL (> 1.5 mg/dL for patients with Gilbert syndrome), Alkaline phosphatase < 2.5 times upper limit of normal, AST < 1.5 times ULN, Serum creatinine normal, BUN normal, Not pregnant or nursing, Fertile patients must use effective contraception, Patients who are status post-revascularization procedures with satisfactory cardiac function, No acute myocardial infarction within the past 6 months, No significant history of a medical problem or co-morbidity that would preclude a major abdominal operation, No concurrent second malignancy requiring systemic therapy, No psychiatric or addictive disorders, or other conditions that would preclude the patient from meeting the study requirements, Patients who received prior adjuvant therapy for colon adenocarcinoma and/or prior first-line systemic therapy for metastatic colon adenocarcinoma are eligible
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing whether using a warmed-up chemotherapy drug called mitomycin C after surgery can help kill leftover cancer cells in patients with advanced colon cancer that has spread to the abdomen. The goal is to see if this approach improves survival and quality of life. Mitomycin C has historically been used in the treatment of intraperitoneal carcinomatosis from colon cancer.

Who is the study for?
This trial is for adults with newly diagnosed colon cancer that has spread to the lining of the abdomen but not beyond. They must be fit for major surgery, have a Peritoneal Cancer Index score ≤20, normal organ function tests, and no severe heart or lung conditions. Pregnant women are excluded and participants must use effective contraception.
What is being tested?
The study is testing if standard chemotherapy treatments for colon cancer work better when combined with surgery and heated mitomycin C (a type of chemotherapy). Patients will be randomly assigned to receive either just the standard therapy or the combination with surgery and mitomycin C.
What are the potential side effects?
Chemotherapy drugs like capecitabine, fluorouracil, cetuximab may cause nausea, vomiting, diarrhea, mouth sores; while mitomycin C can lead to tiredness and more serious blood-related side effects. Surgery carries risks such as infection and bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IIExperimental Treatment11 Interventions
Patients undergo cytoreduction surgery and hyperthermic intraperitoneal mitomycin C over 45-90 minutes. Beginning 8 weeks after surgery, patients receive standard systemic therapy as in arm I. Treatment with systemic therapy repeats for 6 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm IActive Control9 Interventions
Patients receive standard systemic therapy, at the discretion of patients' oncologist, comprising combinations of fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and/or capecitabine (including FOLFOX4, mFOLFOX6, CapeOx, or FOLFIRI), bevacizumab, or cetuximab. Treatment repeats in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may crossover to arm II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Cetuximab
FDA approved
Fluorouracil
FDA approved
FOLFOX regimen
2009
Completed Phase 3
~2440
Capecitabine
FDA approved
Fluorouracil
FDA approved
Irinotecan
FDA approved
Leucovorin
FDA approved
Mitomycin
FDA approved
Oxaliplatin
FDA approved
therapeutic conventional surgery
2003
Completed Phase 3
~12900

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include chemotherapy agents like fluorouracil (5-FU) and oxaliplatin, which disrupt DNA replication and repair, causing cancer cell death. Hyperthermia, or the application of heat, can enhance these effects by increasing drug uptake and cancer cell sensitivity. Heated mitomycin C leverages this by using heat to boost the drug's cytotoxicity, potentially improving treatment efficacy and patient outcomes.
The Treatment of Heterotopic Human Colon Xenograft Tumors in Mice with 5-Fluorouracil Attached to Magnetic Nanoparticles in Combination with Magnetic Hyperthermia Is More Efficient than Either Therapy Alone.Adjuvant perioperative portal vein or peripheral intravenous chemotherapy for potentially curative colorectal cancer: long-term results of a randomized controlled trial.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,660 Total Patients Enrolled
Walter Reed Army Medical CenterLead Sponsor
69 Previous Clinical Trials
20,599 Total Patients Enrolled
Alexander Stojadinovic, MDPrincipal InvestigatorWalter Reed Army Medical Center
2 Previous Clinical Trials
413 Total Patients Enrolled

Media Library

bevacizumab Clinical Trial Eligibility Overview. Trial Name: NCT01167725 — Phase 3
Colorectal Cancer Research Study Groups: Arm I, Arm II
Colorectal Cancer Clinical Trial 2023: bevacizumab Highlights & Side Effects. Trial Name: NCT01167725 — Phase 3
bevacizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT01167725 — Phase 3
~23 spots leftby Sep 2025
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