Chemotherapy sequence for pancreatic cancer treatment

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 evaluates the effects of a sequential chemotherapy regimen using Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable and locally advanced pancreatic adenocarcinoma. The primary goal is to improve the rate of R0 resection, which indicates complete surgical removal of the tumor. Secondary objectives include assessing safety, tolerability, progression-free survival, overall survival, objective response rate, and disease control rate. The study involves patients receiving these treatments and undergoing regular radiological assessments to monitor their condition.

Why it matters

Who can join: the full rules

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 National Comprehensive Cancer Network (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, consider ursodiol or a biliary drainage procedure. If the total bilirubin can be reduced or kept to less than or equal to 3 mg/dL, then this inclusion criteria is met.
* 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.

Where it's running

• Levine Cancer Institute
  Charlotte, North Carolina, United States Recruiting
• Wake Forest Baptist Comprehensive Cancer Center
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Ravi K Paluri, MD, MPH — Wake Forest Baptist Comprehensive Cancer Center
• Study coordinator: Project Manager
• Email: Melani.Terry@advocatehealth.org
• Phone: 336-716-5772

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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.