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CoFactor + Avastin for Colorectal Cancer
Study Summary
This trial is testing whether a different drug given with 5-FU will help people with metastatic colorectal cancer live longer without their disease getting worse.
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.Trial Design
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Who is running the clinical trial?
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- I haven't had chemo or immunotherapy for my advanced cancer, but may have had specific drugs with radiotherapy over 6 months ago.My colon or rectal cancer has spread and cannot be removed with surgery.I can take care of myself but may not be able to do heavy physical work.I have serious non-healing wounds or ulcers.My INR is above 1.5, but it's controlled between 2-3 with a stable dose of anticoagulants.I haven't had radiation therapy in the last 6 weeks or on the cancer spots chosen for this study unless they've gotten worse.I do not have serious heart or blood vessel problems.I am 18 years old or older.My cancer has spread and this was confirmed by tests or allowed exceptions.I finished my previous cancer treatment over 6 months ago, which may have included oxaliplatin and irinotecan.I do not have an ongoing infection and am fever-free.I haven't had major surgery or a serious injury in the last 4 weeks and don't expect to need major surgery during the study.You are expected to live for at least 3 more months.I am not taking sorivudine, Brivudin, or similar drugs.I have a tumor that can be measured by scans.I am allergic or have had a bad reaction to certain chemotherapy drugs.I have been treated with bevacizumab before.I do not have any urgent cancer-related complications like severe swelling, jaundice needing a stent, spinal issues, or uncontrolled bleeding.I have had brain metastasis, a brain tumor, or a stroke.I haven't had a fine needle aspiration or a central line placed in the last week.I have no known allergies to leucovorin or similar drugs.I haven't had a heart attack, stroke, or similar event in the last year.I have an organ transplant and am on immunosuppressive drugs.
- Group 1: 1
- Group 2: 2
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is this study being conducted in more than one state?
"To simplify travel for potential participants, the 46 clinical trial sites are located in or near Freesoil, Apple Valley, Beverly Hills, and other major cities."
How many individuals are included in this research project?
"This particular trial is not searching for any more participants at this time. It was originally posted on May 1st, 2006 and was last edited on November 15th, 2007. If you are interested in other trials, 1204 studies involving rectal carcinoma and 722 5- Fluorouracil (5-FU) trials are currently looking for patients."
Can people with the necessary qualifications join this trial currently?
"According to the latest information on clinicaltrials.gov, this particular trial is not looking for patients at the moment. The trial was first posted on May 1st, 2006 and updated November 15th, 2007. Although this study isn't taking any more participants, there are 1,926 other trials that are presently enrolling subjects."
What else is 5-FU being looked at for in scientific research?
"There are currently 722 ongoing trials for 5-FU, with the majority of them being in Shanghai. Out of these trials, 210 are in Phase 3. Additionally, there are 36549 different locations around the world where studies for 5-FU are taking place."
What is the toxicity profile of 5- Fluorouracil (5-FU)?
"There is pre-existing clinical evidence backing up 5-Fluorouracil's safety, which is why it was given a 3."
What are some of the more common conditions that doctors use 5-FU to treat?
"5-FU, commonly referred to as 5- Fluorouracil, is a medication used to treat malignant neoplasms. In some cases, it has also been effective in treating recurrent platinum sensitive primary peritoneal cancer, rectal carcinoma, and locally advanced nonsquamous non-small cell lung cancer."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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