Study on Treating Basal-like Pancreatic Cancer with Gemcitabine, Erlotinib, and Nab-paclitaxel
Sponsor: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials ID:NCT06483555
This clinical trial is testing a new combination of drugs to find the best dose for treating advanced basal-like pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body.
Patient Parameters
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Program Overview
The study aims to determine the best dose of a new treatment combination for patients with advanced basal-like pancreatic cancer. This involves using low-dose EGFR inhibitors with gemcitabine and nab-paclitaxel, given every two weeks. The study will also look at how safe and effective this treatment is, and how well it can shrink tumors. Patients will be classified as having either 'basal type' or 'classical' pancreatic cancer using a method called PurIST. Those with basal-like cancer will receive the new treatment, while those with classical cancer will receive standard chemotherapy.
Description
The usual treatment for advanced pancreatic cancer includes FOLFIRINOX, NALIRIFOX, or gemcitabine/nab-paclitaxel. However, basal-like pancreatic cancer often does not respond well to FOLFIRINOX. Research suggests that adding an EGFR inhibitor like erlotinib to gemcitabine and nab-paclitaxel may improve outcomes for basal-like pancreatic cancer compared to FOLFIRINOX.
Patients with classical pancreatic cancer will receive standard chemotherapy, while those with basal-like cancer will receive the erlotinib combination. The study's goal is to find the best dose of the erlotinib combination, which is not yet FDA-approved, although the individual drugs are approved for pancreatic cancer. The study will enroll 52 patients with basal-like cancer to test the safety and effectiveness of the treatment. Another 52 patients with classical cancer will receive standard chemotherapy to compare long-term outcomes like survival and tumor response.
The study uses a special design to find safe and effective doses and will expand to include more patients once the best dose is found. This will help determine how well the treatment works for basal-like pancreatic cancer.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent to participate and agree to share personal health information.
- Must be 18 years or older.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must agree to a pre-study biopsy if previous tissue samples are not available.
- Can have other cancers if they do not interfere with the study treatment.
Exclusion Criteria
- Cancer cannot be measured using standard criteria.
- No confirmed diagnosis of metastatic pancreatic cancer.
- No previous treatments focused on the pancreas.
- No brain metastasis diagnosed in the last 4 weeks.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
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