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Tocladesine for Metastatic Colorectal Cancer
Phase 1
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
Performance status: ECOG 0-2
Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN), AST and ALT no greater than 5 times ULN, PT/aPTT no greater than 1.2 times ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well tocladesine works in treating patients with colorectal cancer that has spread to other parts of the body.
Who is the study for?
This trial is for adults aged 18-75 with recurrent or progressive metastatic colorectal cancer that has worsened after treatment with fluorouracil and irinotecan. Participants must not be pregnant, should use contraception if fertile, have no active infections or other cancers in the last 5 years (except certain skin cancers), and their blood counts and organ functions need to meet specific criteria.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a chemotherapy drug called tocladesine on patients with metastatic colorectal cancer that has come back or gotten worse. It's an early-phase study (Phase I) focusing on how well this drug works when previous treatments haven't been successful.See study design
What are the potential side effects?
While specific side effects for tocladesine are not listed here, common side effects of chemotherapy drugs include nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood cell counts, and potential damage to organs like the liver and kidneys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
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My liver function tests are within acceptable ranges.
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My cancer came back or got worse after treatment with fluorouracil and irinotecan.
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I am between 18 and 75 years old.
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My kidney function is normal, with creatinine levels and clearance within the required range.
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My heart functions normally.
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I have been diagnosed with cancer that has spread from my colon or rectum.
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My cancer can be measured by tests.
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 am not on long-term blood thinners.I am able to get out of my bed or chair and move around.My liver function tests are within acceptable ranges.My cancer came back or got worse after treatment with fluorouracil and irinotecan.I am between 18 and 75 years old.My kidney function is normal, with creatinine levels and clearance within the required range.My heart functions normally.I have been diagnosed with cancer that has spread from my colon or rectum.I am not taking any long-term anti-inflammatory drugs.I am not taking any other cancer treatments.My cancer can be measured by tests.I am not pregnant, have no active infections, no recent cancers except certain skin cancers, and if fertile, I use contraception.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- 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.
Is there an opportunity to join this investigation currently?
"Data on clinicaltrials.gov reveals that, while this trial initially began in April 2001 and was last modified in August 2013, it is not currently seeking participants. Nonetheless, there are still 1063 other medical studies actively recruiting patients at the moment."
Answered by AI
Is mature age eligibility permitted in this clinical experiment?
"This clinical trial is open to patients between 18 and 75 years of age."
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Has this therapeutic approach received FDA endorsement?
"As this is a Phase 1 study, the safety of this treatment was estimated to be relatively low with score of 1. There is limited evidence supporting both efficacy and safety at this stage."
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