What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as modified FOLFIRINOX (mFFX) and biweekly Gemcitabine plus Nab-Paclitaxel (mGnabP), are associated with significant side effects. FOLFIRINOX can cause severe neutropenia, fatigue, diarrhea, and peripheral neuropathy. Similarly, the combination of Gemcitabine and Nab-Paclitaxel often results in neutropenia, fatigue, neuropathy, and gastrointestinal issues like diarrhea and nausea. These treatments are effective but require careful monitoring due to their high toxicity.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer that have cytotoxic effects through inhibition of DNA synthesis and disruption of microtubule function. Gemcitabine, a nucleoside analog that inhibits DNA synthesis, was one of the first drugs approved for pancreatic cancer. Nab-paclitaxel, an albumin-bound formulation of paclitaxel that disrupts microtubule function, has also been approved in combination with gemcitabine. This combination has shown improved survival rates in clinical trials. Other similar treatments include FOLFIRINOX, a regimen that includes fluorouracil, leucovorin, irinotecan, and oxaliplatin, which also targets DNA synthesis and microtubule function.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include: 1) Napabucasin combined with nab-paclitaxel and gemcitabine, which targets multiple oncogenic pathways. 2) OGX-427 combined with gemcitabine, which enhances chemosensitivity and induces apoptosis. 3) ATM-3507 combined with antimicrotubule agents, which shows synergy in disabling cancer cell filaments and enhancing cytotoxicity.

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Anti-metabolites

Modified FOLFIRINOX + Gemcitabine/Nab-Paclitaxel for Pancreatic Cancer

Phase 2

Waitlist Available

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

Must not have

Ineligible histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas

History of interstitial lung disease, slowly progressive dyspnea, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis

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

No Placebo-Only Group

Summary

This trial is testing alternating chemotherapy treatments in patients with advanced pancreatic cancer who haven't been treated before. The goal is to see if this approach can keep the cancer from worsening for a longer time compared to using just one treatment. Gemcitabine has been a standard chemotherapy treatment for advanced pancreatic cancer since 1997.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is not one of the excluded types like carcinoid or islet cell.

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I have a history of lung conditions like sarcoidosis or pulmonary fibrosis.

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I do not have any health issues that would stop me from joining the study.

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My cancer has spread to my brain.

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I have not fully recovered from major surgery in the last 4 weeks.

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I do not have severe numbness or pain in my hands or feet.

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I am allergic to one or more of the drugs used in this study.

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I currently have an active infection.

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I have not had a heart attack or significant heart disease in the last 6 months.

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I do not have an active or uncontrolled infection with HIV, Hepatitis B, or Hepatitis C.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline prior to therapy, every 8 weeks interval through duration of therapy, and at end of treatment, average 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to treatment failure (TTF)

Secondary study objectives

Correlation between variation in variant allele fraction (% cfDNA) or amplifications and tumor objective response during chemotherapy

EORTC QLQ-CIPN20 questionnaire

Overall survival (OS)

+3 more

Other study objectives

Correlation between variation of ctDNA and progression free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for pancreatic cancer, such as modified FOLFIRINOX (mFFX) and biweekly Gemcitabine plus Nab-Paclitaxel (mGnabP), work through cytotoxic effects by inhibiting DNA synthesis and disrupting microtubule function. These mechanisms are vital as they target the rapid division of cancer cells, leading to cell death and potentially reducing tumor size and spread. This understanding aids in selecting the most effective therapies and managing side effects, ultimately improving patient outcomes.

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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.