Treatment for advanced basal-like pancreatic cancer using a combination of drugs
Subjects With Advanced Basal-like Pancreatic Adenocarcinoma Treated With Gemcitabine, Erlotinib and Nab-paclitaxel (PANGEA) Versus Subjects With Classical Pancreatic Adenocarcinoma Treated With Triplet Standard of Care Therapy.
This study is testing a new combination of drugs to see if it can help people with advanced basal-like pancreatic cancer feel better when standard treatments aren't working.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | erlotinib, chemotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06483555 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed advanced basal-like pancreatic adenocarcinoma who are willing to comply with study procedures.
Not a fit: Patients with non-measurable disease or those with classical subtype pancreatic adenocarcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with basal-like pancreatic adenocarcinoma, potentially improving their outcomes.
How similar studies have performed: Previous studies have indicated that combining EGFR inhibitors with gemcitabine and nab-paclitaxel may improve treatment responses in basal-like pancreatic cancer, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chapel Hill, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.