Chemotherapy sequence for pancreatic cancer treatment
Sequential Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
This study is testing a new order of chemotherapy drugs to see if it helps people with hard-to-treat pancreatic cancer have their tumors completely removed through surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05825066 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed borderline resectable or locally advanced pancreatic adenocarcinoma.
Not a fit: Patients with non-adenocarcinoma pancreatic tumors or those with significantly compromised organ function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical outcomes and overall survival for patients with challenging pancreatic cancer cases.
How similar studies have performed: While the specific sequence of treatments has not been FDA approved, similar chemotherapy regimens have shown promise in improving outcomes in pancreatic cancer.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Winston-Salem, North Carolina
- 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: Study Coordinator
- Email: Emily.Teal@advocatehealth.org
- Phone: 3367165772
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.