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Anti-metabolite

Nitrocamptothecin vs Fluorouracil for Pancreatic Cancer

Phase 3
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
Histologically or cytologically confirmed recurrent or refractory adenocarcinoma of the pancreas
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 nitrocamptothecin with fluorouracil to see which is more effective in treating pancreatic cancer.

Who is the study for?
This trial is for adults over 18 with recurrent or refractory pancreatic cancer who have previously been treated with gemcitabine. They should be relatively stable (Karnofsky score of 50-100%), not pregnant, willing to use contraception, and have adequate blood counts and liver/kidney function. Those currently on immunotherapy, steroids, hormones, or radiotherapy are excluded.Check my eligibility
What is being tested?
The study aims to find out if nitrocamptothecin is more effective than fluorouracil in treating patients whose pancreatic cancer has returned or didn't respond after treatment with gemcitabine. Patients will randomly receive either nitrocamptothecin or fluorouracil as part of this phase III trial.See study design
What are the potential side effects?
Potential side effects from both drugs may include nausea, vomiting, diarrhea, mouth sores, low blood cell counts leading to increased infection risk and bleeding problems; fatigue; and liver toxicity. The severity can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pancreatic cancer has come back or is not responding to treatment.
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I can perform most of my daily activities without assistance.
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I have been treated with gemcitabine and my condition worsened.
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I am over 18 years old.

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

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Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Lead Sponsor
95 Previous Clinical Trials
7,965 Total Patients Enrolled
Lawrence A. Romel, MSStudy ChairAstex Pharmaceuticals, Inc.
2 Previous Clinical Trials

Media Library

Fluorouracil (Anti-metabolite) Clinical Trial Eligibility Overview. Trial Name: NCT00005871 — 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 medication received formalized sanctioning from the FDA?

"This is a Phase 3 trial, which means that there is already some data supporting both the safety and efficacy of this treatment. Our team at Power has rated the safety of this treatment to be a 3 on a scale from 1 to 3."

Answered by AI

Are there any enrollments left for this clinical trial?

"This particular trial is not taking on any more patients, however there are 724 other clinical trials that might be a match for you. This information comes from clinicaltrials.gov, which also reports that this trial was last updated on 12/3/2013."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
SuperGen, Incorporated
What portion of applicants met pre-screening criteria?
Did not meet criteria
~13 spots leftby Mar 2025