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Anti-metabolites
Modified FOLFIRINOX + Gemcitabine/Nab-Paclitaxel for Pancreatic Cancer
Phase 2
Recruiting
Led By Lyudmyla Berim, MD
Research Sponsored by Lyudmyla Berim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate bone marrow function
At least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline prior to therapy, every 8 weeks interval through duration of therapy, and at end of treatment, average 1 year
Awards & highlights
Study Summary
This trial is testing a new combination therapy for pancreatic cancer to see if it extends time to treatment failure compared to the current standard of care.
Who is the study for?
This trial is for adults with metastatic pancreatic cancer who haven't had treatment for it yet. They need to be in good physical shape, have proper organ function, and agree to use birth control. People can't join if they've had certain other cancers, major surgery recently, infections like HIV or hepatitis, significant heart issues within the past 6 months, or are pregnant.Check my eligibility
What is being tested?
The study tests whether alternating modified FOLFIRINOX (mFFX) with Gemcitabine plus Nab-Paclitaxel improves time before treatment failure compared to just mFFX in those newly diagnosed with metastatic pancreatic cancer.See study design
What are the potential side effects?
Possible side effects include reactions from the chemotherapy drugs such as nausea, fatigue, hair loss, nerve damage leading to numbness or tingling sensations (neuropathy), low blood cell counts increasing infection risk and bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bone marrow is working well.
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I am 18 years old or older.
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My cancer is confirmed as pancreatic adenocarcinoma through testing.
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My blood clotting tests are within normal limits and I'm not on blood thinners.
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I am fully active or can carry out light work.
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I am a woman who can have children and have a negative pregnancy test.
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My condition is stage IV pancreatic cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline prior to therapy, every 8 weeks interval through duration of therapy, and at end of treatment, average 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline prior to therapy, every 8 weeks interval through duration of therapy, and at end of treatment, average 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to treatment failure (TTF)
Secondary outcome measures
Correlation between variation in variant allele fraction (% cfDNA) or amplifications and tumor objective response during chemotherapy
EORTC QLQ-CIPN20 questionnaire
Overall survival (OS)
+3 moreOther outcome measures
Correlation between variation of ctDNA and progression free survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment Regimen: mFOLFIRINOX + mGnabPExperimental Treatment1 Intervention
All study participants will receive the following treatment:
mFOLFIRINOX (28-day cycle)
Day 1 and Day 15:
Oxaliplatin 85 mg/m2 2-hour intravenous infusion followed by leucovorin 400 mg/m2 2-hour infusions with the addition of irinotecan 150 mg/m2 as a 90 minute infusion. 5-FU 2400 mg/m2 continuous intravenous infusion over 46 hours will follow irinotecan.
Day 3 and Day 17:
Pegylated-Granulocyte Colony Stimulating Facotr (peg-GCSF) 6 mg subcutaneous injection following disconnection of 5-FU infusion, first cycle and then per investigator discretion.
Biweekly mGnabP (28-day cycle)
Day 1 and Day 15:
Nab-paclitaxel 125 mg/m2 infused over 30 minutes, immediately followed by Gemcitabine 1200 mg/m2 intravenously infused at the rate of 10mg/m2/min (over 120 minutes).
Patients will receive one month of each regimen, alternately monthly until progression of disease.
Find a Location
Who is running the clinical trial?
Lyudmyla BerimLead Sponsor
Lyudmyla Berim, MD2.01 ReviewsPrincipal Investigator - Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
2Patient Review
My brother was placed under Dr Berim's care with colon cancer. He died less than a month later. We were never told about the potential for infection during chemotherapy. He was taken to ER two days after his second infusion and died of sepsis.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for less than 12 weeks.My bone marrow is working well.My liver is working well.I am willing and able to follow the study's schedule and procedures.I am 18 years old or older.I agree to use effective contraception during my treatment.My cancer is not one of the excluded types like carcinoid or islet cell.My cancer is confirmed as pancreatic adenocarcinoma through testing.I have no cancer history except for certain treated cancers or any cancer I've been free from for 5 years.You have a disease that can be measured or evaluated according to specific guidelines.I have a history of lung conditions like sarcoidosis or pulmonary fibrosis.I do not have any health issues that would stop me from joining the study.Your urine test doesn't show any major problems.My blood clotting tests are within normal limits and I'm not on blood thinners.My cancer has spread to my brain.I have not fully recovered from major surgery in the last 4 weeks.I am fully active or can carry out light work.I do not have severe numbness or pain in my hands or feet.I am a woman who can have children and have a negative pregnancy test.I am allergic to one or more of the drugs used in this study.I currently have an active infection.You are pregnant or breastfeeding.I haven't been treated for metastatic disease, except possibly with 5-FU or gemcitabine as radiation sensitizers.My condition is stage IV pancreatic cancer.I have not had a heart attack or significant heart disease in the last 6 months.I do not have an active or uncontrolled infection with HIV, Hepatitis B, or Hepatitis C.My kidneys are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Regimen: mFOLFIRINOX + mGnabP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many participants are being sought for this research?
"The clinical trial is currently recruiting patients, with 30 participants needed in total from 7 different sites. The listing for the trial was first posted on 1/6/2021 and updated on 9/26/2022 according to information available on clinicaltrials.gov"
Answered by AI
What is the most popular reason that patients take Folfirinox alternating with Gemcitabine-nab-Paclitaxel?
"patients with malignant neoplasms, non-small cell lung carcinoma, and colorectal carcinoma can all be treated using Folfirinox in combination with Gemcitabine-nab-Paclitaxel."
Answered by AI
Are there any other Folfirinox-Gemcitabine-nab-Paclitaxel case studies that we can learn from?
"Currently, there are 1636 clinical trials researching Folfirinox alternating with Gemcitabine-nab-Paclitaxel. The majority of the trials are in Guangzhou, Guangdong, but there are 80409 locations operating clinical trials for this medication."
Answered by AI
Has the FDA given their thumbs up to Folfirinox as a treatment option alongside Gemcitabine-nab-Paclitaxel?
"Folfirinox alternating with Gemcitabine-nab-Paclitaxel is in Phase 2 of clinical trials. This means that while there is evidence supporting its safety, there is none yet for efficacy."
Answered by AI
Are we still able to add test subjects to this experiment?
"This trial, which was originally posted on January 6th 2021, is still actively seeking participants according to clinicaltrials.gov. The last edit to the posting occurred on September 26th 2022."
Answered by AI
How many different sites are participating in this research project?
"There are 7 recruiting patients for this study including RWJBarnabas Health - Saint Barnabas Medical Center, Livingston in Livingston, RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton in Hamilton, and RWJBarnabas Health - Newark Beth Israel Medical Center in Newark. There are also sites at 7 other locations."
Answered by AI
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