64 Participants Needed

Neoadjuvant Chemotherapy for Pancreatic Cancer

SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sequence of chemotherapy drugs for people with pancreatic cancer. It examines the effects—both positive and negative—of administering Gemcitabine (Gemzar) and nab-Paclitaxel (Abraxane) first, followed by mFOLFIRINOX (modified FOLFIRINOX). While these are standard treatments, they are not typically used in this order. The researchers aim to determine if this sequence can improve outcomes for those with borderline resectable or locally advanced pancreatic adenocarcinoma. Participants must have a confirmed diagnosis of pancreatic adenocarcinoma and meet specific health criteria. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 using Gemcitabine, Nab-paclitaxel, and mFOLFIRINOX together is generally safe for treating pancreatic cancer. Studies have compared these treatments to evaluate their effectiveness and safety. Both Nab-paclitaxel with Gemcitabine and mFOLFIRINOX have proven effective for advanced pancreatic cancer and have received FDA approval for this use.

Although these drugs are potent, they can cause side effects such as tiredness, nausea, and low blood cell counts. These side effects are common with chemotherapy and can usually be managed. These treatments have been used for a long time, providing a solid understanding of their safety.

Overall, the treatments are considered well-tolerated. Testing the order of these treatments in the trial is a crucial step to further explore their potential benefits and risks.12345

Why are researchers excited about this trial's treatments?

Most treatments for pancreatic cancer involve chemotherapy regimens like FOLFIRINOX and gemcitabine with nab-paclitaxel. However, this new approach combines both these regimens in a unique sequence to maximize effectiveness. Researchers are excited because it starts with gemcitabine and nab-paclitaxel to shrink the tumor, then switches to mFOLFIRINOX, a potent combo of drugs, aiming for better tumor reduction before surgery. This strategic sequencing could potentially improve outcomes by hitting the cancer with a broader spectrum of chemotherapy agents.

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

In this trial, participants will receive a treatment regimen starting with Gemcitabine and nab-Paclitaxel, followed by mFOLFIRINOX, to evaluate its effectiveness for treating pancreatic cancer. Research has shown that starting with Gemcitabine and nab-Paclitaxel, followed by mFOLFIRINOX, can help patients live longer and increase the chances of successful surgery after treatment. The FDA has already approved Gemcitabine and nab-Paclitaxel for advanced pancreatic cancer, confirming their effectiveness together. FOLFIRINOX, another approved treatment, is also associated with better survival and more successful surgeries for some patients. While using these treatments in this specific order is new, each has proven benefits, making this approach promising for patients.678910

Who Is on the Research Team?

Ravi Kumar Paluri, MD, MPH | Atrium ...

Ravi K Paluri, MD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with borderline resectable or locally advanced pancreatic adenocarcinoma. Participants must be in good physical condition (ECOG 0-1), have adequate organ and marrow function, and not have had prior chemotherapy for pancreatic cancer. They should understand the study and consent to participate.

Inclusion Criteria

I am fully active or can carry out light work.
My blood and organ functions meet the required levels for the trial.
I can understand and am willing to sign the consent form.
See 2 more

Exclusion Criteria

I haven't had cancer in the last 3 years, except for certain skin, cervical, or low-risk prostate cancers.
Patients receiving any other investigational anti-neoplastic agents
I have had chemotherapy with gemcitabine, nab-paclitaxel, or FOLFIRINOX for pancreatic cancer.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX

8 weeks
Weekly visits for chemotherapy administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Gemcitabine
  • mFOLFIRINOX
  • Nab paclitaxel
Trial Overview The trial tests a sequence of chemotherapy treatments: Gemcitabine - Abraxane followed by mFOLFIRINOX, which are FDA-approved individually but not as a combined treatment for this type of cancer. The effect of this sequence on patients' conditions is being studied.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant Chemotherapy (Gemcitabine and nab-Paclitaxel and mFOLFIRNIOX)Experimental Treatment4 Interventions

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Gemzar for:
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Approved in United States as Gemzar for:
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Approved in Canada as Gemzar for:
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Approved in Japan as Gemzar for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 46 patients with resectable pancreatic ductal adenocarcinoma (PDAC) treated with modified FOLFIRINOX, pharmacokinetic-guided dosing of 5-Fluorouracil (5-FU) and Irinotecan (CPT-11) was associated with significantly longer progression-free survival.
Patients with a 5-FU area under the curve (AUC) above 28 mcg·h/mL and CPT-11 AUC below 10 mcg·h/mL had a reduced risk of disease progression, suggesting that tailored chemotherapy dosing can enhance treatment efficacy in PDAC.
Therapeutic drug monitoring of neoadjuvant mFOLFIRINOX in resected pancreatic ductal adenocarcinoma.Vilalta-Lacarra, A., Aldaz, A., Sala-Elarre, P., et al.[2023]
Modified FOLFIRINOX (mFOLFIRINOX) showed moderate efficacy in treating locally advanced or metastatic pancreatic cancer, with a response rate of 30.8% and a disease control rate of 69.2% in 13 patients after previous treatments failed.
The treatment was associated with a median overall survival of 176 days and significant adverse effects, including neutropenia in 38.5% of patients, indicating that while mFOLFIRINOX can be beneficial, it also carries risks that need to be managed.
Modified FOLFIRINOX for Locally Advanced and Metastatic Pancreatic Cancer Patients Resistant to Gemcitabine and S-1 in Japan: A Single Institutional Experience.Umemura, A., Nitta, H., Sasaki, A., et al.[2022]
In a study of 18 patients with locally advanced pancreatic cancer (LAPC), neoadjuvant therapy using FOLFIRINOX resulted in a promising R0 resection rate of 44%, indicating that a significant portion of patients became eligible for surgical removal of their tumors after treatment.
The treatment showed high efficacy with a 1-year overall survival rate of 100% and a progression-free survival rate of 83%, although it was associated with notable chemotherapy-related toxicities, including neutropenia and fatigue.
A retrospective study of neoadjuvant FOLFIRINOX in unresectable or borderline-resectable locally advanced pancreatic adenocarcinoma.Hosein, PJ., Macintyre, J., Kawamura, C., et al.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/41072417/
Neoadjuvant nab-paclitaxel plus gemcitabine followed by ...Neoadjuvant nab-paclitaxel plus gemcitabine followed by modified FOLFIRINOX for resectable pancreatic cancer: A randomized phase 3 trial.
Neoadjuvant nab-paclitaxel plus gemcitabine followed by ...Neoadjuvant nab-paclitaxel plus gemcitabine followed by modified FOLFIRINOX for resectable pancreatic cancer: A randomized phase 3 trial.
Pathologic and clinical outcomes after neoadjuvant ...A systemic review and meta-analysis of FOLFIRINOX vs gemcitabine plus nab-paclitaxel in the neoadjuvant treatment of localized pancreatic cancer ...
Comparative Effectiveness of FOLFIRINOX Versus ...FOLFIRINOX is associated with improved overall survival and higher post-chemotherapy surgical resection rates in uLAPC patients.
a multicentre, open-label, phase 3 randomised trialThis randomised trial did not show a difference in overall survival between neoadjuvant FOLFIRINOX and neoadjuvant gemcitabine-based ...
The efficacy and safety of Nab-paclitaxel plus gemcitabine ...AG and FFX showed comparable efficacy outcomes in patients with metastatic pancreatic cancer. Pancreatic cancer patients receiving first-line ...
Efficacy and safety of FOLFIRINOX versus gemcitabine- ...Results: FOLFIRINOX-treated patients (n = 3,020) demonstrated significantly longer overall survival (OS) than gemcitabine-treated patients (n = ...
Modified FOLFIRINOX vs Gemcitabine/Nab-Paclitaxel in ...In the ITT population, median overall survival was 8.5 months in the mFOLFIRINOX group vs 9.7 months in the gemcitabine/nab-paclitaxel group (HR ...
Outcomes of FOLFIRINOX versus Gemcitabine plus nab- ...Two phase III trials conducted in the 2010s revealed that FOLFIRINOX and GEM plus nab-paclitaxel (GnP) are more effective than GEM monotherapy ...
FOLFIRINOX vs Gemcitabine Plus Nab-Paclitaxel for ...Using cross-institutional clinical analysis, we found that treatment with FOLFIRINOX was associated with more than 2 months of survival ...
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