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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
Study Summary
This trial is studying standard therapy with or without surgery and mitomycin C to see how well it works in treating patients with advanced limited peritoneal dissemination of 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.Check my eligibility
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.See study design
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Circulating tumor cells
Comparison of OS and PFS according to patients' peritoneal surface tumor genotype for the NAD(P)H
Progression-free survival (PFS)
+2 moreTrial 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
Capecitabine
FDA approved
Fluorouracil
FDA approved
Cetuximab
FDA approved
Bevacizumab
FDA approved
Irinotecan
FDA approved
Leucovorin
FDA approved
Mitomycin
FDA approved
Oxaliplatin
FDA approved
Fluorouracil
FDA approved
FOLFOX regimen
2009
Completed Phase 3
~2440
therapeutic conventional surgery
2003
Completed Phase 3
~12270
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,813 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
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Arm I
- Group 2: Arm II
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are there any dangers to using bevacizumab?
"There is some evidence backing the efficacy of bevacizumab as well as numerous rounds of data affirming its safety, so it received a 3."
Answered by AI
What are some standard treatments that involve bevacizumab?
"bevacizumab is a medication with diverse applications. Small cell lung cancer (sclc) is the primary condition that bevacizumab is used to treat. However, it can also be used as a treatment for glaucoma, rectal carcinoma, and colorectal carcinoma."
Answered by AI
Are there any vacant slots in this clinical trial for new patients?
"This particular clinical trial is not recruiting at the moment. The first posting was on August 1st, 2010 and the last edit was on January 21st, 2012. If the individual is looking for other studies, there are 1257 trials for colorectal cancer and 1277 bevacizumab trials that are currently recruiting patients."
Answered by AI
Could you tell us about other investigational uses of bevacizumab?
"Bevacizumab was first studied in 2000 at Wellington Hospital. Since then, there have been 2709 completed clinical trials. There are currently 1277 active studies, with a large number being performed out of Winston-Salem, North carolina."
Answered by AI
How many guinea pigs are being used in this experiment?
"This study is not recruiting patients at the moment. It was originally posted on 8/1/2010 and was last edited on 1/21/2012. If you are interested in other studies, there are 1257 trials for colorectal cancer and 1277 trials for bevacizumab that are actively enrolling patients."
Answered by AI
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