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Anti-cancer agent
Chemotherapy +/− SU5416 for Colorectal Cancer
Phase 3
Waitlist Available
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No known brain or leptomeningeal metastases
Histologically confirmed adenocarcinoma of the colon or rectum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will compare the effectiveness of combination chemotherapy with or without SU5416 in treating patients who have metastatic colorectal cancer.
Who is the study for?
This trial is for adults with newly diagnosed or recurrent metastatic colorectal cancer. They should be in good physical condition (ECOG 0-1), have proper liver and kidney function, no severe heart issues, no active inflammatory bowel disease or significant bowel obstruction, not HIV positive, and without a history of other cancers within the last 5 years. Women must not be pregnant/nursing and willing to use contraception.Check my eligibility
What is being tested?
The study is testing if adding SU5416 to standard combination chemotherapy improves treatment outcomes for metastatic colorectal cancer compared to chemotherapy alone. Patients are randomly assigned to either receive SU5416 with their chemo or just chemo.See study design
What are the potential side effects?
Chemotherapy can cause side effects like nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts. SU5416 may add risks such as bleeding problems since it affects blood flow to tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have cancer spread to my brain or its coverings.
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My cancer is a type of colon or rectal cancer confirmed by a lab test.
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My condition is either newly diagnosed or has come back.
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I am 18 years old or older.
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My metastatic disease has not been treated and can be measured.
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I am fully active or can carry out light work.
Timeline
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
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Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,075 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,153 Total Patients Enrolled
Lee S. Rosen, MDStudy ChairJonsson Comprehensive Cancer Center
5 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had specific advanced cancer treatments or been in another clinical trial recently.I do not have cancer spread to my brain or its coverings.I haven't had a heart attack, stroke, or serious heart issues in the last 6 months.I do not have ongoing severe bowel problems.My cancer is a type of colon or rectal cancer confirmed by a lab test.My condition is either newly diagnosed or has come back.I am 18 years old or older.My liver tests are significantly higher than normal.My creatinine levels are more than 1.5 times the upper normal limit.My metastatic disease has not been treated and can be measured.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 significant risks associated with this treatment plan?
"As this is a Phase 3 trial, there are multiple rounds of data that support the safety of this intervention. Our team therefore rates it as safe."
Answered by AI
Are we currently enrolling patients for this research project?
"The clinical trial mentioned is not currently looking for new participants, as stated on clinicaltrials.gov. The study was first posted on December 1st, 2000 and edited most recently on December 18th, 2013. There are however, 1108 other trials which are still recruiting patients."
Answered by AI
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