Actively Recruiting
Subjects With Advanced Basal-like Pancreatic Adenocarcinoma Treated With Gemcitabine, Erlotinib and Nab-paclitaxel Versus Subjects With Classical Pancreatic Adenocarcinoma Treated With Standard Triplet Therapy
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-04-23
104
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab-paclitaxel (GnP) is safe, tolerable, and helpful for people with advanced pancreatic cancer. The study focuses on tumors classified as either "basal-like" or "classical" using the PurIST tool. Participants with basal-like tumors will receive the combination of GnP plus erlotinib in Phase I to find the safest dose. In Phase II, basal-like patients will be randomly assigned to receive either GnP alone or GnP with erlotinib, with possible testing of new drug combinations if approved during the study. Classical tumor patients will receive standard treatments recommended by their doctors or participate in other clinical trials. Participants with basal-like tumors will be treated with gemcitabine (1000 mg/m2 intravenously on days 1 and 15), nab-paclitaxel (125 mg/m2 intravenously on days 1 and 15), and erlotinib (50 mg orally daily) during Phase I and possibly Phase II. Those with classical tumors will receive treatments such as NALIRIFOX or Folfirinox as decided by their physicians. The study may include up to about 52 basal-like patients in Phase I, about 82 basal-like patients in Phase II, and at least 52 classical patients, with the option to enroll more if needed. Participants will be screened using the PurIST classifier to determine tumor type before treatment. Researchers will monitor adverse events, dose-limiting toxicities, overall survival, progression-free survival, and tumor response over two years. Safety is assessed from the first day of treatment through 28 days after the last dose. The study also tracks long-term outcomes such as survival time and tumor progression. Participation involves regular treatment visits, medical evaluations, and follow-up assessments to understand the effects of the treatments tested.
CONDITIONS
Brief Title
Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization obtained
- Age 18 years or older at consent
- ECOG Performance Status of 0-1
- Histological or cytological confirmation of unresectable, borderline resectable, or metastatic pancreatic adenocarcinoma
- Consent to a mandatory pre-study biopsy if archival tissue is not sufficient
- Prior standard-of-care neoadjuvant therapy allowed
- May have received up to two cycles of first-line FOLFIRINOX or NALIRIFOX
- Prior brain metastasis allowed if treatment completed at least 4 weeks prior, off corticosteroids for 2 weeks, and asymptomatic
You will not qualify if you...
- Disease not measurable by RECIST v1.1 criteria
- No histological or cytological confirmation of metastatic pancreatic adenocarcinoma
- Treatment with any investigational drug or prior cancer treatment within 28 days before study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days after last treatment
Participants with basal-like pancreatic carcinoma receive combination therapy with Gemcitabine, Nab-paclitaxel, and Erlotinib, while participants with classical pancreatic adenocarcinoma receive standard triplet therapy as decided by their physician.
Repeated visits for treatment administration and monitoring during the therapy period
Duration - Up to 2 years
Participants are monitored for adverse events, progression-free survival, and overall survival for up to 2 years after treatment.
Periodic follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
C
Catherine A Griffin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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