PIPAC + Nab-paclitaxel for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of delivering chemotherapy directly into the abdomen for individuals with pancreatic cancer that has spread only to the abdominal lining. The goal is to determine if this approach can improve quality of life and extend survival by targeting treatment precisely while minimizing side effects. It suits those diagnosed with pancreatic cancer confined to the abdomen who are not candidates for more aggressive surgery. This method uses Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC) combined with Nab-paclitaxel, a chemotherapy drug. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this PIPAC is safe for pancreatic cancer patients?
A previous study found PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) to be generally safe. Researchers used it with drugs like cisplatin and doxorubicin, and no major safety issues arose. Another report indicated that only 6.2% of patients experienced serious complications with PIPAC, which is quite low, suggesting it is well-tolerated.
For nab-paclitaxel, commonly used for pancreatic cancer, research has shown that some patients may experience side effects like low white blood cell count, low red blood cell count, and nerve damage. However, nab-paclitaxel is already approved for treating pancreatic cancer when used with gemcitabine, indicating it is considered safe for this purpose.
Overall, both PIPAC and nab-paclitaxel have shown evidence of safety. However, since this trial is in an early phase, it primarily focuses on further confirming their safety.12345Why do researchers think this study treatment might be promising for pancreatic cancer?
Unlike the standard treatments for pancreatic cancer, which typically involve systemic chemotherapy like FOLFIRINOX or gemcitabine with nab-paclitaxel, PIPAC + nab-paclitaxel offers a unique delivery method. PIPAC stands for Pressurized Intraperitoneal Aerosolized Chemotherapy, and it allows chemotherapy to be delivered directly into the abdominal cavity in an aerosolized form. This targeted approach potentially enhances drug penetration into cancerous tissues while minimizing systemic side effects. Researchers are excited because this method could improve efficacy in patients with peritoneal-only metastasis from pancreatic cancer, offering a more localized and potentially more effective treatment option.
What evidence suggests that PIPAC with nab-paclitaxel could be an effective treatment for pancreatic cancer?
This trial will evaluate the safety of combining PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) with nab-paclitaxel for patients with pancreatic cancer that has spread to the abdominal lining. Studies have shown that PIPAC can safely and effectively treat cancers affecting the abdominal lining by delivering chemotherapy directly to the tumor, potentially enhancing drug delivery and reducing side effects. Although limited data exists specifically for pancreatic cancer with abdominal spread, combining nab-paclitaxel with other chemotherapy drugs like gemcitabine has improved survival rates in pancreatic cancer. These treatments have shown promise in enhancing both quality of life and survival for various cancers affecting the abdominal lining.678910
Are You a Good Fit for This Trial?
This trial is for adults with pancreatic cancer that has spread only to the lining of the abdomen (peritoneal metastasis). Participants must be well enough to handle treatment, have good organ function, and not have other serious illnesses or cancer outside the abdomen. Pregnant people and those with severe heart, lung, or liver problems can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive up to 3 treatments of PIPAC with nab-paclitaxel in conjunction with standard of care systemic therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and progression-free survival
Extension (optional)
Potential opportunity to extend treatment outside of the trial for compassionate use
What Are the Treatments Tested in This Trial?
Interventions
- Nab-paclitaxel
- Pressurized Intraperitoneal Aerosolized Chemotherapy (PIPAC)
Trial Overview
The study is testing a new way to deliver chemotherapy called PIPAC using nab-paclitaxel directly into the abdomen as an aerosol during surgery. This will be combined with standard care treatments chosen by their oncologist. The goal is to see if this approach improves outcomes for these patients.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This study is a prospective single center, non-randomized phase I trial to confirm the safety of PIPAC with nab- paclitaxel in conjunction with standard of care systemic therapy in patients with peritoneal-only metastasis from PDAC. The efficacy signals noted in this trial will inform a potential phase II/III multicenter clinical trial. Patients may receive up to 3 treatments whilst enrolled on the study, with a potential opportunity to extend outside of the trial for compassionate use.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
Citations
Clinical efficacy of nab-paclitaxel in patients with metastatic ...
In our cohort of patients, we found a significant impact using nab-paclitaxel plus Gem on CA 19-9 reduction (>50%). In particular, the mean reduction was 55% ( ...
Increased Survival in Pancreatic Cancer with nab ...
In patients with metastatic pancreatic adenocarcinoma, nab-paclitaxel plus gemcitabine significantly improved overall survival, progression-free survival, and ...
Certepetide Plus Gemcitabine and Nab-Paclitaxel Shows ...
Results revealed that the 6-month PFS rate was 49.0% (95% CI, 36.4%-60.5%) in the investigational arm vs 40.8% (95% CI, 22.6%-58.3%) in the ...
Phase II clinical trial of nab‐paclitaxel plus cisplatin ... - PMC
NABPLAGEM has efficacy in advanced PDAC, demonstrating early disease control noted by improvement in patient symptoms, decrease in tumor volume and tumor ...
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 ...
A Review on the Efficacy and Safety of Nab-Paclitaxel ... - PMC
The advent of a therapy that decreases adverse events and improves overall survival outcomes in pancreatic cancer patient populations will be a milestone in ...
Nab-Paclitaxel plus Gemcitabine and FOLFOX in Metastatic ...
The median overall survival was 13.2 months (95% CI, 10.1 to 16.2) with nab-P/Gem-mFOLFOX and 9.7 months (95% CI, 7.5 to 12) with nab-P/Gem ( ...
Efficacy and safety of second-line nab-paclitaxel plus ...
Most common grade 3-4 adverse events were neutropenia (36%), anemia (9%), and peripheral neuropathy (8%). Conclusions: In medically fit pts with ...
ABRAXANE® for Metastatic Pancreatic Cancer | for HCPs
ABRAXANE is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
Distinct safety profiles of albumin-bound nab-paclitaxel and ...
Nab-paclitaxel was associated with a significantly higher number of reports for pancreatic cancer, with 4080 cases compared to 397 cases for ...
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