Modified FOLFIRINOX + Gemcitabine/Nab-Paclitaxel for Pancreatic Cancer

Not currently recruiting at 6 trial locations

Overseen By Lyudmyla Berim, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lyudmyla Berim

Disqualifiers: CNS metastases, Cardiac disease, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new combination of cancer drugs can extend the time people with advanced pancreatic cancer live without treatment failure. The study tests a mix of two chemotherapy regimens, Modified FOLFIRINOX and Gemcitabine/nab-Paclitaxel, to assess whether their combined use is more effective than using either regimen alone. It seeks participants with a specific type of advanced pancreatic cancer who have not yet received treatment for their metastatic disease and can meet the trial's demands. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that modified FOLFIRINOX (mFOLFIRINOX) is generally safe for people with pancreatic cancer. One study found that mFOLFIRINOX is easier for patients to handle than the standard version, resulting in fewer side effects. This makes it a safer choice for some individuals.

Studies on Gemcitabine plus nab-Paclitaxel (mGnabP) also demonstrate good safety results. A major study showed that using these drugs together improved survival rates without causing severe side effects. Another study confirmed that mGnabP is more effective and safer than using Gemcitabine alone.

Both treatments have undergone testing in previous studies and are considered safe for humans. Participants reported manageable side effects, supporting the safety of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the modified FOLFIRINOX combined with gemcitabine and nab-paclitaxel for pancreatic cancer because it has the potential to improve treatment effectiveness. Unlike the current standard treatments, which often involve either FOLFIRINOX or gemcitabine with nab-paclitaxel alone, this regimen combines both approaches. This dual strategy targets cancer cells using different mechanisms, possibly leading to better outcomes. Additionally, incorporating pegylated-granulocyte colony-stimulating factor helps manage side effects and maintain white blood cell counts, potentially allowing patients to tolerate the treatment better.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer?

Research has shown that a treatment called modified FOLFIRINOX (mFOLFIRINOX) works well for pancreatic cancer. One study found that 52.9% of patients experienced tumor shrinkage, and 11.7% saw their cancer disappear completely, resulting in an 88.2% disease control rate. In this trial, participants will receive a regimen that includes both mFOLFIRINOX and the combination of Gemcitabine and nab-Paclitaxel. Studies have found that this combination helps patients with advanced pancreatic cancer live longer. Specifically, one study demonstrated that patients lived significantly longer with this combination than with Gemcitabine alone. Together, these treatments offer hope for effectively managing pancreatic cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Lyudmyla Berim, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My bone marrow is working well.

My liver is working well.

I am willing and able to follow the study's schedule and procedures.

Exclusion Criteria

Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he/she were to participate in the study

You are expected to live for less than 12 weeks.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive alternating cycles of mFOLFIRINOX and biweekly Gemcitabine plus Nab-Paclitaxel

24 weeks

Biweekly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for long-term safety and survival outcomes

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Folfirinox
• Gemcitabine-nab-Paclitaxel

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment Regimen: mFOLFIRINOX + mGnabP Experimental Treatment 1 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.

Folfirinox is already approved in United States, European Union for the following indications:

Approved in United States as FOLFIRINOX for:

• Pancreatic cancer

Approved in European Union as FOLFIRINOX for:

• Pancreatic cancer

Who Is Running the Clinical Trial?

Lyudmyla Berim

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

In a single-center experience involving two cases of locally advanced pancreatic cancer, patients initially treated with neoadjuvant FOLFIRINOX chemotherapy, which had high response rates but potential hematologic toxicity, showed disease progression.

Subsequent treatment with nab-paclitaxel and gemcitabine resulted in significant response rates and a reasonable safety profile, suggesting this combination may be a viable second-line option for patients with unresectable pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resection of Locally Advanced Pancreatic Neoplasms after Neoadjuvant Chemotherapy with Nab-Paclitaxel and Gemcitabine following FOLFIRINOX Failure. Hahn, S., Ayav, A., Lopez, A.[2020]

In a study of 568 patients with metastatic pancreatic cancer, gemcitabine combined with nab-paclitaxel (GnP) showed a higher disease control rate (82.6%) compared to modified FOLFIRINOX (mFFX) (67.9%), indicating better effectiveness in managing the disease.

Patients receiving mFFX experienced significantly more severe nonhematologic side effects, such as grade 3/4 anorexia and diarrhea, suggesting that GnP may be a safer option with fewer severe adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Treatment Outcomes Between Gemcitabine With Nab-Paclitaxel and Modified FOLFIRINOX for First-Line Chemotherapy in Metastatic and Recurrent Pancreatic Cancer: Propensity Score Matching. Mie, T., Sasaki, T., Takeda, T., et al.[2023]

In a meta-analysis of 16 studies involving 3813 patients with metastatic pancreatic cancer, both GEM-NAB and FOLFIRINOX showed similar overall survival rates, despite FOLFIRINOX having a numerically longer median overall survival.

GEM-NAB was associated with lower rates of nausea and severe neutropenia compared to FOLFIRINOX, while FOLFIRINOX had lower rates of neurotoxicity and anemia, indicating that the choice between these treatments may depend on the patient's tolerance to side effects rather than a clear efficacy advantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Gemcitabine plus Nab-Paclitaxel and FOLFIRINOX in the First-Line Setting of Metastatic Pancreatic Cancer: A Systematic Review and Meta-Analysis. Pusceddu, S., Ghidini, M., Torchio, M., et al.[2020]

In a study of 28 patients with advanced pancreatic cancer, the combination of gemcitabine plus nab-paclitaxel (G + Nab-P) after FOLFIRINOX showed a median time to treatment failure of 12 weeks and a median overall survival of 23 weeks, indicating modest efficacy.

The treatment was associated with significant hematologic toxicities, with 25% of patients experiencing anemia and thrombocytopenia, highlighting the need for careful monitoring and further research on optimal dosing and sequencing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine plus nab-paclitaxel for advanced pancreatic cancer after first-line FOLFIRINOX: single institution retrospective review of efficacy and toxicity. Zhang, Y., Hochster, H., Stein, S., et al.[2022]

A study of 5465 patients with advanced pancreatic cancer in Ontario showed that the introduction of new chemotherapy regimens, GEMNAB and FOLFIRINOX, significantly improved overall survival rates over time, with median survival increasing from 5.6 months to 7.6 months between 2008 and 2018.

FOLFIRINOX was found to provide better overall survival compared to GEMNAB, particularly in younger and healthier patients, while GEMNAB still showed improved survival compared to the older standard treatment, gemcitabine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association of Drug-Funding Reimbursement With Survival Outcomes and Use of New Systemic Therapies Among Patients With Advanced Pancreatic Cancer. Raphael, MJ., Raskin, W., Habbous, S., et al.[2023]

In a study of 54 patients with advanced pancreatic cancer, S-IROX showed a higher disease control rate (73.7%) compared to modified FOLFIRINOX (mFFX) (62.2%), indicating it may be more effective as a second-line treatment after gemcitabine plus nab-paclitaxel.

Both S-IROX and mFFX had similar overall survival rates (14.2 months for S-IROX and 11.5 months for mFFX) and tolerability, with no significant differences in severe side effects, suggesting both regimens are viable options for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective comparative study of S-IROX and modified FOLFIRINOX for patients with advanced pancreatic cancer refractory to gemcitabine plus nab-paclitaxel. Saito, K., Nakai, Y., Takahara, N., et al.[2022]

The introduction of FOLFIRINOX and gemcitabine plus nab-paclitaxel therapy significantly improved treatment outcomes for metastatic pancreatic cancer, with response rates increasing from 7.8% to 28.4% after these therapies were introduced.

Patients treated with the newer therapies experienced longer median progression-free survival (3.1 months to 5.4 months) and median overall survival (6.7 months to 10.2 months), indicating a substantial benefit in daily clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Treatment Outcomes for Metastatic Pancreatic Cancer: A Real-world Data Analysis. Sasaki, T., Kanata, R., Yamada, I., et al.[2022]

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