Treatment for advanced basal-like pancreatic cancer using a combination of drugs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety, tolerability, and efficacy of a combination treatment involving gemcitabine, nab-paclitaxel, and erlotinib for patients with advanced unresectable or metastatic basal-like pancreatic adenocarcinoma. The research aims to determine the optimal dosing of this combination therapy, as previous studies suggest that basal-like subtypes do not respond well to standard treatments like FOLFIRINOX. Patients will undergo a mandatory biopsy to confirm their cancer subtype, and those with classical subtypes will receive standard chemotherapy instead. The study employs a two-stage design to evaluate safe dosing and treatment response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
* Age ≥ 18 years at the time of consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Histological or cytological evidence/confirmation of unresectable, borderline resectable, or metastatic (basal-like and classical) pancreatic adenocarcinoma.
* The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
* Subjects may have received prior standard-of-care (SOC) neoadjuvant therapy and may have received up to two cycles of first-line FOLFIRINOX or NALIRIFOX.
* A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study treatment have been off of corticosteroids for ≥ 2 weeks and are asymptomatic.

Exclusion Criteria:

* Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1
* Not having histological or cytological evidence/confirmation of metastatic pancreatic adenocarcinoma.
* Treatment with any investigational drug or prior cancer treatment within 28 days prior to study treatment

Where it's running

• University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Ashwin Somasundaram, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Catherine A Griffin
• Email: catherine_griffin@med.unc.edu
• Phone: 1 984-974-8771

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.