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Genotype-Directed Chemotherapy for Colorectal Cancer
Study Summary
This trial is testing a new way to give colon cancer patients a standard combination chemotherapy treatment, which includes the anti-cancer drugs 5-Fluorouracil (5FU), leucovorin and irinotecan (known as FOLFIRI), plus the anti-angiogenesis drug bevacizumab (Avastin). The study is designed to test the FOLFIRI regimen based on certain characteristics of a person's genetic makeup or "genes".
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 4 trial • 128 Patients • NCT01588990Trial Design
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- My cancer has spread and cannot be removed by surgery to cure it.I can stop taking certain medications and avoid specific fruits for the required time before starting my treatment.I have had hypertensive encephalopathy in the past.My urine tests show significant protein levels.I have coughed up a noticeable amount of blood recently.I haven't had any stomach or intestine tears in the last 6 months.I am willing to have a genetic test for UGT1A1.I do not have a bleeding disorder or significant blood clotting issues.My blood, kidney, and liver tests are within normal ranges.I haven't had major surgery or serious injuries in the last 28 days and don't expect to need major surgery during the study.I agree to use birth control during the study.I haven't had a stroke or mini-stroke in the last 6 months.My alkaline phosphatase levels are within the normal range.I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.I am not taking any other cancer treatments or experimental drugs while on this study therapy.I have not had surgery (except for a device placement) within the last week.I have a heart condition.I have a serious wound or bone fracture that is not healing.I have not had a heart attack or unstable chest pain in the last 6 months.I have a known DPD deficiency.My heart condition is at least moderate in severity.I am 18 years old or older.I am able to get out of my bed or chair and move around.My UGT1A1 genotype does not match *1/*1, *1/*28, or *28/*28.I do not have any serious health issues that would stop me from following the treatment plan.My cancer is confirmed to be adenocarcinoma of the colon or rectum.I have signed the consent form approved by the ethics committee.I haven't had chemotherapy for cancer that has spread.I have been treated with irinotecan and/or bevacizumab before.
- Group 1: *1/*1 Genotype
- Group 2: *28/*28
- Group 3: *1/*28 Genotype
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
In how many different medical centers is this research study being conducted today?
"This trial has 7 enrolling sites, with Cone Health Cancer Center in Greensboro, University of North carolina in Chapel Hill, and IU Arnett Hospital in Lafayette being 3 of them."
Are there other ongoing medical studies that are using Irinotecan?
"At this time, 834 clinical trials are underway to study the efficacy of Irinotecan. Of these 226 live trials, the majority (202) are in Phase 3. Most of these Shanghai-based trials are taking place in China (39489 locations), but there are other global sites as well."
Are there any vacancies in this clinical trial for new participants?
"This study is not recruiting at the moment, however it was last updated on 6/7/2022. There are a total of 834 trials for Irinotecan and 257 clinical trials for malignant neoplasm of colon currently enrolling patients if you're interested in other studies."
Has the FDA sanctioned Irinotecan for public use?
"There is some clinical data supporting the safety of Irinotecan, but none for efficacy. As such, it was given a score of 2."
What are the standard conditions that Irinotecan helps to improve?
"While rectal carcinoma is the most common reason to use Irinotecan, this medication can also be helpful for patients with colorectal carcinoma, sarcoma, and locally advanced nonsquamous non-small cell lung cancer."
How many people are taking part in this research?
"As of right now, this particular trial is not looking for new patients. However, there are a total of 834 clinical trials enrolling Irinotecan participants and 257 studies seeking patients with malignant neoplasm of the colon."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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