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Topoisomerase I inhibitor
Nitrocamptothecin for Colorectal Cancer
Phase 2
Waitlist Available
Research Sponsored by Astex Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No more than 1 prior fluorouracil based chemotherapy regimen for metastatic disease
At least 1 bidimensionally measurable indicator lesion that has not been irradiated and meets specific size criteria for different types of lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well nitrocamptothecin works in treating patients with colorectal cancer that has spread or returned.
Who is the study for?
This trial is for patients with advanced or recurrent colorectal cancer who have previously been treated with fluorouracil-based chemotherapy. They must have at least one measurable tumor and normal organ function, not be pregnant or nursing, and agree to use contraception. Patients who've had certain other treatments like nitrocamptothecin are excluded.Check my eligibility
What is being tested?
The study is testing the effectiveness of a chemotherapy drug called nitrocamptothecin in patients with colorectal cancer that has either come back or hasn't responded to previous treatment. It's a Phase II trial, which means it focuses on how well the drug works and monitors side effects.See study design
What are the potential side effects?
While specific side effects for nitrocamptothecin aren't listed here, common ones from similar chemotherapy drugs include nausea, vomiting, diarrhea, fatigue, low blood counts leading to increased infection risk, liver issues, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had only one chemotherapy with fluorouracil for my advanced cancer.
Select...
I have a cancer lesion that can be measured in two directions and hasn't been treated with radiation.
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?
Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,961 Total Patients Enrolled
Show-Li Sun, MDStudy ChairAstex Pharmaceuticals, Inc.
7 Previous Clinical Trials
113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My colorectal cancer returned or worsened after fluorouracil chemotherapy.I am not using, nor plan to use, effective birth control for 6 months after the study.My previous treatments do not meet the specific criteria for this trial.My liver function tests are within normal limits.My kidney function is within normal limits.I have had only one chemotherapy with fluorouracil for my advanced cancer.I have previously been treated with fluorouracil or its combinations.I had fluorouracil as a preventive treatment over a year ago.My age does not affect my eligibility.I am mostly bedridden due to my health condition.I have a cancer lesion that can be measured in two directions and hasn't been treated with radiation.
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.
Are there still vacancies available to join this research?
"Clinicaltrials.gov states that this medical trial, which first began on September 1st 1999 and was last updated in December 2013, is not presently enrolling patients. Despite the lack of new participants for this study, there are 1064 other clinical studies actively accepting volunteers at the moment."
Answered by AI
To what extent does this intervention pose risk to patients?
"Our team at Power has tentatively rated the safety of this treatment a 2 due to the lack of data on efficacy, despite Phase 2 trials suggesting some evidence for its security."
Answered by AI
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