Nab-paclitaxel + Gemcitabine for Pancreatic Cancer
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.12345Why 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.46789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy
Participants receive 3 cycles of neoadjuvant combination chemotherapy of nab-paclitaxel and gemcitabine
Re-staging and SBRT
Re-staging CT scan followed by stereotactic body radiotherapy (SBRT) if no metastatic disease is present
Surgical Resection
Definitive surgical resection of the tumor
Adjuvant Chemotherapy
Participants receive 3 cycles of adjuvant combination chemotherapy of nab-paclitaxel and gemcitabine
Follow-up
Participants are monitored for safety and effectiveness after treatment with surveillance CT scans at 3-month intervals
What Are the Treatments Tested in This Trial?
Interventions
- Gemcitabine
- Nab-paclitaxel
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Academic Thoracic Oncology Medical Investigators Consortium
Lead Sponsor
Celgene Corporation
Industry Sponsor
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
University of Colorado, Denver
Collaborator