35 Participants Needed

Nab-paclitaxel + Gemcitabine and mFOLFIRINOX for Pancreatic Cancer

CR
Overseen ByCancer Research Nurse
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Dartmouth-Hitchcock Medical Center
Stay on Your Current MedsYou can continue your current medications while participating
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 explores the effects and safety of a combination of chemotherapy drugs on pancreatic cancer that is difficult to remove surgically. The focus is on using two treatments: Nab-paclitaxel with Gemcitabine and a modified version of FOLFIRINOX (mFOLFIRINOX), administered before surgery to shrink the tumor. Suitable candidates have been diagnosed with borderline resectable pancreatic cancer and have not yet received chemotherapy or radiation treatments. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in pancreatic cancer treatment.

Do I need to stop my current medications to join the trial?

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 shows that the combination of nab-paclitaxel and gemcitabine is generally well-tolerated by patients with pancreatic cancer. Some studies indicate that this treatment can extend patient survival. While side effects may occur, they are often manageable and similar to those of other cancer treatments.

Modified FOLFIRINOX (mFOLFIRINOX) is another effective and tolerable treatment option. Patients using mFOLFIRINOX often live longer compared to those using treatments like gemcitabine alone. However, like most chemotherapy treatments, it may also have side effects.

Both treatments have demonstrated safety in previous studies for many patients. Individual experiences can vary, so discussing potential side effects with a healthcare provider is important.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Nab-paclitaxel, Gemcitabine, and mFOLFIRINOX for pancreatic cancer because it brings together two potent chemotherapy regimens in a new way. Traditional treatments for pancreatic cancer often involve either FOLFIRINOX or Nab-paclitaxel plus Gemcitabine alone. This trial combines them to potentially enhance effectiveness, especially in patients with borderline resectable pancreatic ductal adenocarcinoma. By administering this combination as neoadjuvant therapy, researchers are hopeful it will shrink tumors more effectively before surgery, offering a new strategy to improve surgical outcomes and overall survival rates.

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

This trial will evaluate the effectiveness of two treatment options for pancreatic cancer: a combination of nab-paclitaxel and gemcitabine, and modified FOLFIRINOX (mFOLFIRINOX). Studies have shown that combining nab-paclitaxel with gemcitabine can extend survival in pancreatic cancer patients. Specifically, one study found that 16% of patients treated with this combination lived for a year without disease progression, compared to 9% of those who received only gemcitabine. Additionally, research indicates that modified FOLFIRINOX can prolong survival more effectively than gemcitabine alone. In one study, patients on modified FOLFIRINOX lived without the disease for about 21.4 months, longer than with other treatments. These findings suggest that both treatment options could be effective for pancreatic cancer.24678

Are You a Good Fit for This Trial?

This trial is for adults over 18 with borderline resectable pancreatic cancer (BR-PDAC), confirmed by a specialized tumor board. Participants must be in good physical condition, not pregnant or breastfeeding, willing to use contraception, and able to consent. They can't have certain blood abnormalities, organ dysfunctions, genetic mutations related to cancer treatment response, prior PDAC treatments, other active cancers needing treatment during the study period or severe neuropathy.

Inclusion Criteria

Patients must be able and willing to provide informed consent
Contrast-enhanced CT scan of the chest, abdomen, and pelvis performed within 45 days before registration
I am 18 years old or older.
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Exclusion Criteria

Baseline laboratory abnormalities: ANC < 2,500/mm3, Platelet count < 100,000/mm3, Hemoglobin < 7 g/dL, Creatinine > 1.5 x ULN, Total bilirubin > 1.5 x ULN, AST/ALT > 5 x ULN
Patients who are pregnant or breastfeeding
Patients who are incarcerated
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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 alternating neoadjuvant chemotherapy with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOX

12-16 weeks

Radiation

Participants undergo radiation therapy prior to surgery

4-6 weeks

Surgery

Participants undergo surgery for tumor removal

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • modified FOLFIRINOX (mFOLFIRINOX)
  • Nab-paclitaxel + Gemcitabine
Trial Overview The trial examines the effects and safety of alternating two chemotherapy regimens—Nab-paclitaxel plus Gemcitabine and modified FOLFIRINOX (mFOLFIRINOX)—on patients with borderline resectable pancreatic cancer. The goal is to see if this approach improves outcomes before potential surgery.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment with Gemcitabine plus Nab-Paclitaxel and mFOLFIRINOXExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials
548
Recruited
2,545,000+

Citations

NALIRIFOX versus nab-paclitaxel and gemcitabine in ...Pancreatic ductal adenocarcinoma remains one of the most lethal malignancies, with an estimated 5-year survival of only 3% for patients ...
Adjuvant Gemcitabine and Nab-Paclitaxel Misses the ...Tempero et al 1 report nab-paclitaxel + gemcitabine did not improve independently assessed disease-free survival as adjuvant therapy in pancreas adenocarcinoma ...
Increased Survival in Pancreatic Cancer with nab ...The rate of progression-free survival at 1 year was 16% in the nab-paclitaxel–gemcitabine group, as compared with 9% in the gemcitabine group. The median ...
NAB-paclitaxel and gemcitabine in metastatic pancreatic ...Our results confirm that combination of gemcitabine plus Nab-P is effective both in terms of overall response rate, progression-free survival ...
Efficacy of gemcitabine plus nab-paclitaxel in second-line ...This study demonstrates the contribution of gemcitabine plus nab-paclitaxel in both OS and PFS in second-line treatment of metastatic pancreatic cancer.
Efficacy and safety of the S-1, nab-paclitaxel, and gemcitabine ...The S-1/nab-paclitaxel/gemcitabine triplet regimen appears to improve survival outcomes while demonstrating potentially favorable tolerability ...
Efficacy and safety of KN046 plus nab-paclitaxel/ ...Conclusions: Combining KN046 with nab-paclitaxel and gemcitabine as first-line treatment for unresectable locally advanced or metastatic PDAC ...
Efficacy and toxicity of gemcitabine plus nab-paclitaxel in ...The median progression-free survival (mPFS) was 3.7 months [95% confidence interval (CI): 2.5–5.3] and the median overall survival (mOS) was 5.6 ...
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