Nab-paclitaxel + Gemcitabine for Pancreatic Cancer

No longer recruiting at 3 trial locations

Overseen By Chalaunda Scott

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Academic Thoracic Oncology Medical Investigators Consortium

Must not be taking: Full dose warfarin

Disqualifiers: Unresectable PDAC, Metastatic PDAC, others

Stay on Your Current Meds You can continue your current medications while participating

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: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of combining nab-paclitaxel (a type of chemotherapy) and gemcitabine before surgery to treat resectable pancreatic cancer. The goal is to determine if this approach can completely remove the cancer. Participants will also receive stereotactic body radiotherapy (SBRT), a type of targeted radiation therapy, before surgery and additional chemotherapy afterward. The trial suits those diagnosed with pancreatic cancer that can potentially be surgically removed, with no signs of spreading. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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

The trial does not specify if you need to stop taking your current medications, but you cannot take full dose warfarin (a blood thinner) and must switch to another allowed medication like low molecular weight heparin or rivaroxaban before starting the trial.

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

Research has shown that the combination of nab-paclitaxel and gemcitabine has been tested for safety in people with pancreatic cancer. Studies confirm that this combination is generally well-tolerated, even in everyday medical settings. The findings suggest that patients can undergo this treatment without major problems.

For instance, one study found that nab-paclitaxel with gemcitabine was effective as an initial treatment for advanced pancreatic cancer and did not cause any unexpected side effects. While patients might experience some common side effects, these are manageable. Another study comparing this combination to gemcitabine alone also found it to be safe.

Overall, while side effects can occur, the combination of nab-paclitaxel and gemcitabine is considered safe enough for use in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Researchers are excited about the combination of nab-paclitaxel and gemcitabine for pancreatic cancer because it offers a fresh approach to treatment. Unlike the standard of care, which typically involves gemcitabine alone or in combination with other drugs like FOLFIRINOX, this combination includes nab-paclitaxel, which helps deliver the chemotherapy more effectively to the cancer cells. This duo is given both before and after surgery, potentially improving outcomes by shrinking tumors before surgery and reducing recurrence afterward. Additionally, the use of stereotactic body radiation therapy (SBRT) in conjunction with these drugs could further enhance their effectiveness by precisely targeting cancer cells.

What evidence suggests that nab-paclitaxel and gemcitabine could be effective for pancreatic cancer?

A previous study found that patients with pancreatic cancer treated with a combination of nab-paclitaxel and gemcitabine lived an average of 8.5 months, compared to 6.7 months for those who received only gemcitabine. This combination also delayed cancer progression. Another study demonstrated that using nab-paclitaxel and gemcitabine as a second treatment option improved survival in patients with advanced pancreatic cancer. These findings suggest that the combination may be more effective than gemcitabine alone for treating pancreatic cancer. In this trial, researchers will test the combination of nab-paclitaxel and gemcitabine for its potential to help patients with resectable pancreatic ductal adenocarcinoma (R-PDAC) and borderline resectable pancreatic ductal adenocarcinoma (BR-PDAC) by shrinking tumors before surgery and aiding recovery afterward. ^{4 6 7 8 9}

Who Is on the Research Team?

Wells Messersmith

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

Adults over 18 with resectable or borderline-resectable pancreatic cancer, without distant metastasis. They must have good performance status, adequate organ function, no prior treatments for pancreatic cancer, and agree to use contraception. Excludes those with unresectable or metastatic disease, recent major surgery, significant heart issues, uncontrolled infections or gastrointestinal disorders.

Inclusion Criteria

My nerve damage in hands/feet is mild or none.

My cancer has not spread to distant parts of my body.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

External biliary drains

Participation in any investigational drug study within 4 weeks preceding the start of study treatment

I do not have any serious infections needing antibiotics.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive 3 cycles of neoadjuvant combination chemotherapy of nab-paclitaxel and gemcitabine

12 weeks

Regular visits for chemotherapy administration

Re-staging and SBRT

Re-staging CT scan followed by stereotactic body radiotherapy (SBRT) if no metastatic disease is present

4 weeks

1 visit for re-staging CT, multiple visits for SBRT

Surgical Resection

Definitive surgical resection of the tumor

1 week

1 visit for surgery

Adjuvant Chemotherapy

Participants receive 3 cycles of adjuvant combination chemotherapy of nab-paclitaxel and gemcitabine

12 weeks

Regular visits for chemotherapy administration

Follow-up

Participants are monitored for safety and effectiveness after treatment with surveillance CT scans at 3-month intervals

Up to 74 months

Surveillance CT scans every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine
• Nab-paclitaxel

Trial Overview

The trial tests a combination of nab-paclitaxel and gemcitabine chemotherapy followed by stereotactic body radiotherapy (SBRT) on patients with operable pancreatic tumors. It aims to determine the success rate of complete tumor removal without microscopic residual disease in two patient groups: R-PDAC and BR-PDAC.

How Is the Trial Designed?

Group I: Nab-paclitaxel and Gemcitabine for R-PDAC Experimental Treatment 2 Interventions

Nab-paclitaxel and gemcitabine, for R-PDAC patients enrolled in this trial, will be given in combination as neoadjuvant combination chemotherapy, followed by SBRT. This is will be followed up by surgical resection and an additional combination chemotherapy of nab-paclitaxel and gemcitabine as adjuvant chemotherapy.

Group II: Nab-paclitaxel and Gemcitabine for BR-PDAC Experimental Treatment 2 Interventions

Nab-paclitaxel and gemcitabine, for BR-PDAC patients enrolled in this trial, will be given in combination as neoadjuvant combination chemotherapy, followed by SBRT. This is will be followed up by surgical resection and an additional combination chemotherapy of nab-paclitaxel and gemcitabine as adjuvant chemotherapy.

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

Approved in European Union as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in United States as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Canada as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Approved in Japan as Gemzar for:

• Pancreatic cancer
• Breast cancer
• Ovarian cancer
• Non-small cell lung cancer

Who Is Running the Clinical Trial?

Academic Thoracic Oncology Medical Investigators Consortium

Lead Sponsor

Trials

5

Recruited

190+

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University

Criterium, Inc.

Industry Sponsor

Trials

18

Recruited

730+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Citations

1.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1304369

Increased Survival in Pancreatic Cancer with nab ...

The median overall survival was 8.5 months in the nab-paclitaxel–gemcitabine group as compared with 6.7 months in the gemcitabine group (hazard ratio for death, ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6254624/

Efficacy of Nab-Paclitaxel Plus Gemcitabine and ...

The primary outcome measures were OS and progression-free survival (PFS). OS was determined from the date of first chemotherapy to death from any cause, whereas ...

3.

nature.com

nature.com/articles/s41598-025-96157-6

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.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02023021

Nab-paclitaxel Combined With Gemcitabine as Adjuvant ...

Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than 5%. About 25% of patients have the opportunity for radically surgical ...

5.

cda-amc.ca

cda-amc.ca/sites/default/files/DRR/2024/PX0354-Nab-Paclitaxel-in-Combo-Gemcitabine_combined.pdf

Bound (Nab)-Paclitaxel (in Combination With Gemcitabine)

The use of OS and PFS as efficacy outcomes in both studies by Huh et al.2 and Mita et al 3 is clinically relevant, given the poor prognosis associated with PDAC ...

6.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.22.01134

Adjuvant nab-Paclitaxel + Gemcitabine in Resected ...

This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02267707

Pharmacokinetic and Safety Study of Nab®-Paclitaxel (ABI ...

The purpose of this study is to determine the safety and pharmacokinetic profile of nab®-paclitaxel (ABI-007) plus gemcitabine in subjects with advanced ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1424390324000772

Treatment outcomes of gemcitabine plus nab-paclitaxel in ...

Gemcitabine plus nab-paclitaxel (GnP) therapy has been shown to improve the prognosis in patients with metastatic pancreatic cancer (PC); however, the efficacy ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32957885/

Clinical Outcomes and Safety of Patients Treated with NAb ...

Our results confirm the efficacy and safety of a first-line regimen comprising gemcitabine and Nab-paclitaxel in metastatic PDAC in a real-life population.