Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Apr 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with certain types of pancreatic cancer that are difficult to remove through surgery. Specifically, it looks at the effects of giving two types of chemotherapy—Gemcitabine with Abraxane followed by mFOLFIRINOX—in that order. While both treatments are already approved for pancreatic cancer, this specific sequence has not been approved yet. The goal is to understand how well this combination works and what side effects it may cause.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of pancreatic adenocarcinoma that is either borderline resectable or locally advanced. You should be in good overall health, with specific blood counts, and not have had certain other treatments for pancreatic cancer before. If you join the study, you will receive the chemotherapy treatments and be monitored closely by the medical team for any benefits or side effects. It's important to know that the trial is currently recruiting participants, and you'll need to provide informed consent, meaning you understand the study and agree to take part.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients must have histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled
• • Patients with borderline resectable or locally advanced pancreatic adenocarcinoma as assessed per NCCN guidelines (either pancreatic head, neck, uncinate process, or body/tail) or institutional multidisciplinary consensus
• • Age 18 or above
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
• * Patients must have organ and marrow function as defined below:
• • Hemoglobin\* ≥8 g/dL Absolute neutrophil count ≥1,500/mcL Platelets\* ≥100,000/mcL Total bilirubin\* ≤1.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal Creatinine ≤1.5 X institutional upper limit of normal or CrCL\>50
• • It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.
• • If obstructive jaundice is present, then biliary drainage must be initiated and total bilirubin less than or equal to 3.0.
• • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• • Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative)
• Exclusion Criteria:
• • Patients who have had prior chemotherapy with gemcitabine and/or nab-paclitaxel or FOLFIRINOX for pancreatic cancer
• • Patients receiving any other investigational anti-neoplastic agents
• • History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible
• • Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy for the infection is completed
• • Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the patient's safety
• • Patients with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis requiring oxygen supplementation. Those that do not require oxygen supplementation are eligible.
• • Patients who have undergone surgery, other than diagnostic or minor procedures, within 4 weeks prior to the initiation of study treatment
• • Patients who are pregnant or breastfeeding