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Alkylating agents
Hepatic Artery Chemotherapy for Pancreatic Cancer
Phase 4
Recruiting
Led By Daniel Nussbaum, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status 0-1
Age >= 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years post-operatively
Awards & highlights
Study Summary
This trial will investigate the safety and feasibility of adding single-dose neoadjuvant HA chemotherapy to standard-of-care treatment for localized PDAC to better determine best sequence of surgery and chemotherapy.
Who is the study for?
This trial is for adults over 18 with localized pancreatic cancer who are fit (ECOG 0-1) and eligible for surgery and chemotherapy. They must have good organ function, agree to use contraception if fertile, and not be pregnant or breastfeeding. Exclusions include recent major surgeries, other interventional trials participation during the study period, severe medical conditions, liver cirrhosis, high CA 19-9 levels before surgery, history of certain cancers within two years or prior liver surgery.Check my eligibility
What is being tested?
The trial tests single-dose neoadjuvant Hepatic Artery (HA) chemotherapy using FUDR/oxaliplatin in patients with pancreatic cancer scheduled for resection and systemic chemo. It aims to determine the safety of adding HA chemo before standard treatments across different treatment sequences. Patients will be monitored short-term post-surgery then every three months up to three years for survival outcomes.See study design
What are the potential side effects?
Potential side effects from HA chemotherapy may include reactions at the infusion site, possible damage to liver tissue due to targeted delivery of drugs via hepatic artery, general side effects from chemotherapeutic agents like fatigue, nausea/vomiting, low blood counts leading to increased infection risk or bleeding complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
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I am using birth control and my pregnancy test was negative.
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My blood tests and organ functions are within normal ranges.
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My pancreatic cancer is confirmed and considered operable after evaluation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years post-operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of HA Chemotherapy for PDAC
Safety of HA Chemotherapy for PDAC
Secondary outcome measures
Disease Free Survival
Liver metastasis-free survival
Overall Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: PDAC with HA ChemotherapyExperimental Treatment1 Intervention
On Day 1 of the treatment period, patients will undergo standard-of-care diagnostic laparoscopy to confirm the absence of metastatic disease not seen on staging imaging, as well as tissue acquisition (blood and liver biopsies) for pre-specified correlative scientific studies. On Day 2 (±1 day), patients will receive the interventional treatment, which is neoadjuvant HA chemotherapy. On Day 14 (±5 business days), patients will undergo standard-of-care resection of their primary tumor, as well as tissue acquisition (blood, liver biopsies, primary tumor, regional lymph nodes) for pre-specified correlative scientific studies.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,476 Total Patients Enrolled
Daniel Nussbaum, MDPrincipal InvestigatorDuke Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am using birth control and my pregnancy test was negative.I do not have any severe or uncontrolled health conditions.I have a serious wound or fracture that is not healing.I have hepatitis B or C.I am currently taking medication for an infection.I am on long-term steroids or medications that suppress my immune system.I have liver cirrhosis.My doctor has approved me for FOLFIRINOX treatment.My blood tests and organ functions are within normal ranges.I am fully active or can carry out light work.I do not have active hepatitis or unresolved blockage in my bile ducts.I have had a stem cell transplant from a donor.My liver's blood vessels cannot be accessed with a needle through the skin.I am not willing to use birth control.I have not had major surgery or a serious injury in the last 28 days.My CA 19-9 levels were above 500 close to my surgery date.You are expected to live for more than 3 months.I haven't had any other cancers in the last 2 years, except for those considered cured.I have had liver surgery, such as part of my liver removed or a liver transplant.My pancreatic cancer is confirmed and considered operable after evaluation.
Research Study Groups:
This trial has the following groups:- Group 1: PDAC with HA Chemotherapy
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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 adverse effects might be associated with Pancreatic ductal adenocarcinoma and Hematological Antineoplastic Chemotherapy?
"With Phase 4 trials indicating PDAC and HA Chemotherapy's safety, it has been assigned a score of 3."
Answered by AI
Are doctors enrolling new participants in this research endeavor?
"According to clinicaltrials.gov, this particular medical trial is not presently enrolling participants. Although it first appeared on April 1st 2023 and was last updated on November 22nd 2022, there are 643 other trials actively recruiting patients at present time."
Answered by AI
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