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Anti-tumor antibiotic

Chemotherapy Regimens for Colorectal Cancer

Phase 3
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum that is not amenable to potentially curative therapy
Performance status: Karnofsky 50-100%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will compare three chemotherapy regimens to see which is more effective in treating metastatic colorectal cancer.

Who is the study for?
This trial is for adults with metastatic colorectal cancer who've had one prior chemotherapy regimen but not specific treatments like adjuvant irinotecan or oxaliplatin. They should have measurable disease progression, no severe health issues like heart failure, uncontrolled diabetes, or active infections, and must not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study aims to compare three different chemotherapy regimens to find out which is most effective in treating patients with metastatic colorectal cancer that has progressed after initial treatment.See study design
What are the potential side effects?
Chemotherapy can cause side effects such as fatigue, nausea and vomiting (despite anti-emetics), blood cell count changes increasing infection risk, potential damage to nerves causing numbness or tingling sensations (neuropathy), and may affect liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My colon or rectum cancer has spread and cannot be cured with surgery or radiation.
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I can perform most of my daily activities without assistance.
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My liver function tests are within the required limits.
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My heart condition is stable, and I haven't had a recent heart attack.
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I am 18 years old or older.
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I do not have lung fibrosis or interstitial pneumonia.
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My kidney function, measured by creatinine, is within normal limits.

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

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,480 Total Patients Enrolled
Mace L. Rothenberg, MD, FACPStudy ChairVanderbilt-Ingram Cancer Center
4 Previous Clinical Trials
589 Total Patients Enrolled

Media Library

Fluorouracil (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00008281 — Phase 3
Colorectal Cancer Research Study Groups:
Colorectal Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT00008281 — Phase 3
Fluorouracil (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00008281 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this course of medication been cleared by the FDA?

"The safety of this Phase 3 trial's treatment was rated a 3 by our team at Power. This is because there is both efficacy data and multiple rounds of safety data supporting this estimation."

Answered by AI

Will this study be enrolling new participants soon?

"The most recent update on clinicaltrials.gov indicates that this study wrapped up recruitment on January 3rd, 2014. The trial was first posted on October 1st, 2000. There are currently 1108 other trials that are actively looking for participants."

Answered by AI

Is this clinical trial being conducted exclusively in the United States?

"Presently, this clinical trial is enrolling patients at 100 sites. A few of these locations are Winston-Salem, Titusville and Mobile. If you are considering enrolling, it may be beneficial to pick a site close to your home to reduce travel time and associated costs."

Answered by AI

Who else is applying?

What state do they live in?
Nova Scotia
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Willamette Valley Cancer Center
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Cancer Centers of the Carolinas
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
2000. "Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00008281.
All > Lynch Syndrome > Ic
~14 spots leftby Apr 2025
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