Gemcitabine + Nab-Paclitaxel for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies how well a biologically optimized infusion schedule of gemcitabine and nab-paclitaxel works in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Altering the timing of the nab-paclitaxel infusion may improve response in patients with pancreatic cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does mention that patients must not have received previous chemotherapy or investigational therapy for metastatic pancreatic cancer, except under certain conditions. It's best to discuss your current medications with the trial team to get a clear answer.
Is the combination of Gemcitabine and Nab-Paclitaxel safe for treating pancreatic cancer?
The combination of Gemcitabine and Nab-Paclitaxel is generally considered safe for treating pancreatic cancer, with most side effects being manageable. Common side effects include neutropenia (low white blood cell count) and peripheral neuropathy (nerve damage), which were mostly reversible with dose adjustments.12345
What makes the drug Gemcitabine + Nab-Paclitaxel unique for treating pancreatic cancer?
The combination of Gemcitabine and Nab-Paclitaxel is unique because it significantly improves survival rates in patients with metastatic pancreatic cancer compared to Gemcitabine alone. Nab-Paclitaxel is a special formulation that avoids certain toxicities and enhances the effectiveness of Gemcitabine, making it a valuable option for this condition.13678
What data supports the effectiveness of the drug combination Gemcitabine and Nab-Paclitaxel for treating pancreatic cancer?
Research shows that the combination of Gemcitabine and Nab-Paclitaxel significantly improved survival in patients with advanced pancreatic cancer compared to Gemcitabine alone. This combination has become a standard treatment option for metastatic pancreatic cancer following positive results from a global phase III trial.23479
Who Is on the Research Team?
Laith Abushahin, MBBS
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with metastatic pancreatic adenocarcinoma confirmed by tissue analysis. Participants must have measurable tumors, not be pregnant or breastfeeding, and agree to use effective contraception. No prior chemotherapy for metastatic cancer is allowed, but past adjuvant therapy over 6 months ago is acceptable. They need a certain level of blood cells (neutrophils, platelets) and hemoglobin.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gemcitabine IV over 30 minutes on days 1 and 15 and nab-paclitaxel IV over 30 minutes on days 3 and 17. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment
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:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laith Abushahin
Lead Sponsor
Anne Noonan
Lead Sponsor
National Cancer Institute (NCI)
Collaborator