Chemotherapy for Pancreatic Cancer
Trial Summary
What is the purpose of this trial?
This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.
Will I have to stop taking my current medications?
The trial requires that you stop taking any strong CYP3A4 inhibitors or inducers at least 14 days before starting the study treatment. If you're on these medications, you'll need to discontinue them before joining the trial.
What data supports the effectiveness of the drugs used in the chemotherapy for pancreatic cancer trial?
What safety data exists for chemotherapy treatments like Gemcitabine, Cisplatin, and Nab-paclitaxel in humans?
What makes the chemotherapy treatment for pancreatic cancer unique?
This chemotherapy treatment for pancreatic cancer is unique because it combines cisplatin, gemcitabine, and nab-paclitaxel, which are known to be effective in other cancers like ovarian cancer, where paclitaxel is used for platinum-resistant cases. This combination may offer a novel approach by leveraging the strengths of each drug to potentially improve outcomes in pancreatic cancer.910111213
Eligibility Criteria
This trial is for adults with metastatic pancreatic cancer that has spread and have a BRCA1, BRCA2, or PALB2 gene mutation. They should not have had cisplatin before but may have had gemcitabine and nab-paclitaxel if it was over a year ago. Participants must show disease progression after initial chemotherapy and be recovered from any significant side effects of previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive chemotherapy with nab-paclitaxel, gemcitabine, and cisplatin or nab-paclitaxel and gemcitabine on days 1 and 15 of each 28-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Cisplatin
- Gemcitabine
- Nab paclitaxel
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator