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Topoisomerase I inhibitors
Nitrocamptothecin 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
Karnofsky performance status 50-100%
Histologically or cytologically proven adenocarcinoma of the pancreas with failure or relapse after at least 1 prior chemotherapy regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is comparing the effectiveness of nitrocamptothecin to other chemotherapy drugs for cancer of the pancreas.
Who is the study for?
This trial is for adults over 18 with recurrent or refractory pancreatic cancer who have tried at least one chemotherapy regimen. Participants must have adequate blood, liver, and kidney function and not be pregnant or nursing. They should not have had certain treatments recently and must agree to use contraception.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of a chemotherapy drug called nitrocamptothecin against other chemotherapies in patients with pancreatic cancer that has come back or didn't respond to previous treatment. It's a phase III trial where patients are randomly assigned to different treatments.See study design
What are the potential side effects?
Chemotherapy drugs like nitrocamptothecin can cause side effects such as nausea, vomiting, hair loss, fatigue, decreased blood cell counts leading to increased infection risk, bleeding or anemia issues, and potential liver or kidney problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can perform most of my daily activities without assistance.
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My pancreatic cancer has returned or worsened after at least one chemotherapy treatment.
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I am over 18 years old.
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
Lawrence A. Romel, MSStudy ChairAstex Pharmaceuticals, Inc.
2 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need considerable assistance and medical care.I can perform most of my daily activities without assistance.I have had chemotherapy with gemcitabine or fluorouracil.I am over 18 years old.I am currently on hormone therapy for cancer.My pancreatic cancer has returned or worsened after at least one chemotherapy treatment.I am taking filgrastim and nitrocamptothecin together.I have previously been treated with nitrocamptothecin or similar drugs.I am younger than 18 years old.I am currently receiving immunotherapy for cancer.I am currently receiving chemotherapy for cancer.I will not have major surgery within 8 weeks after starting treatment.I am currently receiving radiotherapy for cancer.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has this course of action been cleared by the FDA?
"Since this is a Phase 3 trial, there is both some efficacy data and multiple rounds of safety data, so the Power team rates the safety of this treatment as a 3."
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?
Met criteria
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