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Liposomal Irinotecan for Pancreatic Cancer
Study Summary
This trial is testing a new combination of drugs to treat pancreatic cancer. The drugs will be given to patients to see if they are effective and tolerable.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I don't have any other cancer needing treatment in the last 2 years, except for minor skin cancers or cancers that have been inactive for 5+ years.I am taking medications that cannot be changed and are not allowed in this study.I do not have an ongoing serious infection.I am 18 years old or older.My pancreatic cancer is advanced and cannot be surgically removed.My liver functions are within the required range for the trial.I agree to use two forms of birth control or abstain from activities that could result in pregnancy during and after the trial.My recent tests show my organs are functioning well.I have been mostly active and able to carry on all pre-disease activities without restriction in the last 28 days.I do not have severe nerve damage in my hands or feet.I am allergic to certain cancer drugs or their ingredients.I understand the study's purpose, can follow its procedures, and have signed the consent form.I have not had major surgery in the last 4 weeks.I do not have severe heart issues or recent major heart events.My diagnosis of pancreatic cancer is confirmed by lab tests.I am not pregnant and have had a negative pregnancy test recently.My kidney function is within the required range.
- Group 1: FOLFOX + Irinotecan
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there numerous medical centers trialing this experiment in North America?
"The search for participants is underway at 4 primary sites: Penn State Cancer Institute in Hershey, Northwestern University Feinberg School of Medicine in Chicago, and Indiana University Melvin and Bren Simon Comprehensive Cancer Center in Indianapolis. Additionally, there are other locations involved with this recruitment effort."
Can you provide an overview of existing research on Liposomal Irinotecan?
"As of now, 263 experiments centered around Liposomal Irinotecan are ongoing with 53 being in their terminal phase. Although numerous trials for this medication happen in Woolloongabba, Queensland, there are 8,629 places globally where clinical studies examining its efficacy take place."
Does the FDA sanction Liposomal Irinotecan for medicinal use?
"Liposomal Irinotecan has demonstrated some safety in Phase 2 trails, so it was assessed a score of 2. Nevertheless, no efficacy data exists for this medication."
Are there any current openings to participate in this clinical experiment?
"According to data housed on clinicaltrials.gov, enrollment is ongoing for this research project which was initially released on September 2nd 2020 and recently amended on October 21st 2022."
How many individuals can participate in this experiment at its peak?
"In order to complete the trial, Ipsen requires 28 eligible participants. The study will be administered from two locations: Penn State Cancer Institute in Hershey, Pennsylvania and Northwestern University Feinberg School of Medicine in Chicago, Illinois."
What therapeutic purpose does Liposomal Irinotecan typically serve?
"Liposomal Irinotecan is typically used to treat pancreatic malignancies, however it may also serve as a solution for metastatic neoplasm of the stomach, rhabdomyosarcomas and more."
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