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Antimetabolites
Combination Chemotherapy for Pancreatic Cancer
Phase 2
Waitlist Available
Led By Jill Lacy, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No significant cardiac disease
No history of chronic diarrhea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing a combination of drugs to see if they can shrink a pancreatic tumor before surgery and kill any remaining cells after surgery.
Who is the study for?
This trial is for patients with localized pancreatic cancer who haven't had previous treatments. They should be able to undergo surgery, have no other cancers or major health issues like heart disease, uncontrolled seizures, serious lung fibrosis, or severe nerve damage in the hands and feet. Participants need good organ function and an ECOG performance status of 0-1 (fully active or restricted in physically strenuous activity but ambulatory).
What is being tested?
The study tests a combination of chemotherapy drugs (leucovorin calcium, fluorouracil, irinotecan hydrochloride, oxaliplatin) given before and after surgery to see if they can shrink pancreatic tumors pre-surgery and eliminate remaining cancer cells post-surgery.
What are the potential side effects?
Chemotherapy may cause side effects such as nausea, vomiting, diarrhea, fatigue, mouth sores, low blood cell counts leading to increased infection risk or bleeding problems. There's also a chance of nerve damage that could result in tingling or numbness in the hands and feet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have serious heart problems.
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I do not have a history of chronic diarrhea.
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I do not have any other type of cancer.
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I am fully active or can carry out light work.
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I do not have lung fibrosis or pneumonia.
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I do not have uncontrolled seizures, active brain diseases, or known brain disorders.
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My diagnosis of pancreatic cancer is confirmed by lab tests.
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I do not have severe numbness or pain in my hands or feet.
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
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression free survival rate
Secondary study objectives
Overall survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (mFOLFIRINOX)Experimental Treatment6 Interventions
NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.
ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved
Fluorouracil
FDA approved
therapeutic conventional surgery
2003
Completed Phase 3
~12900
Leucovorin
FDA approved
Irinotecan
FDA approved
Find a Location
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,910 Previous Clinical Trials
3,038,946 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,791 Total Patients Enrolled
Jill Lacy, MDPrincipal InvestigatorYale University
1 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood tests for counts, hemoglobin, creatinine, bilirubin, AST, and ALT need to be within a certain range, and women of childbearing age must have a negative pregnancy test.My pancreatic cancer can be surgically removed and hasn't spread outside the pancreas.I do not have serious heart problems.I do not have a history of chronic diarrhea.I do not have any other type of cancer.I am fully active or can carry out light work.I do not have lung fibrosis or pneumonia.My organs are working well.I do not have uncontrolled seizures, active brain diseases, or known brain disorders.You have the tissue samples needed for the study.My diagnosis of pancreatic cancer is confirmed by lab tests.I do not have severe numbness or pain in my hands or feet.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (mFOLFIRINOX)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
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