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Anti-metabolite
Nitrocamptothecin vs Gemcitabine 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
Hepatic: SGOT and SGPT no greater than 3 times normal (5 times normal if liver tumor present), Bilirubin no greater than 2.0 mg/dL
Renal: Creatinine no greater than 2.0 mg/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will compare nitrocamptothecin with gemcitabine to see which is more effective in treating pancreatic cancer.
Who is the study for?
Adults with advanced pancreatic cancer that can't be surgically removed may join this trial. They should not have had previous chemotherapy, except for fluorouracil as a radiosensitizer. Participants need to have normal organ function and cannot be pregnant or nursing. Effective contraception is required for fertile participants.Check my eligibility
What is being tested?
This phase III trial compares two chemotherapy drugs: nitrocamptothecin and gemcitabine, to see which one is more effective in treating advanced pancreatic cancer. Patients are randomly assigned to receive either drug.See study design
What are the potential side effects?
Chemotherapy drugs like nitrocamptothecin and gemcitabine can cause side effects such as nausea, vomiting, fatigue, low blood cell 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...
My liver function tests are within the required limits.
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My creatinine level is 2.0 mg/dL or lower.
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I am over 18 years old.
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I can perform most of my daily activities without assistance.
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My pancreatic cancer is advanced and cannot be removed by surgery.
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:- My pancreatic cancer is advanced and cannot be removed by surgery.My liver function tests are within the required limits.My creatinine level is 2.0 mg/dL or lower.I've only had fluorouracil with radiation, no other chemo treatments.I had major surgery over 2 weeks ago and have recovered, with no surgeries planned soon.I am over 18 years old.You must be at least 18 years old and in good overall health. Your blood cell counts, liver function, and kidney function must be within certain normal ranges. If you can get pregnant, you must use effective birth control.I am not on hormonal or corticosteroid therapy, or if I am, it's for other medical reasons.I can perform most of my daily activities without assistance.I haven't had biologic therapy in the last 3 weeks and have recovered from it.It's been over 3 weeks since my last radiotherapy and I've recovered.My pancreatic cancer is advanced and cannot be removed by surgery.
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.
What are the potential risks of this treatment for patients?
"There is some evidence from earlier trials to support the efficacy of this treatment, as well as multiple rounds of data supporting safety. Consequently, our team has given it a score of 3 for safety."
Answered by AI
Can people with the qualifying condition still enroll in this research?
"Unfortunately, this particular trial is not seeking new participants at the moment. However, there are 725 other clinical trials with open recruitment currently underway."
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Met criteria
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