Clinical trial NCT05825066: Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Official title: Sequential Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreas Adenocarcinoma
Borderline Resectable Pancreatic Adenocarcinoma
Locally Advanced Pancreatic Adenocarcinoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-04-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.

Detailed description: Primary Objective:

- The primary objective of this study is to evaluate the efficacy of sequential Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in improving R0 resection rate in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer.

Secondary Objectives:

* Evaluate the safety and tolerability of sequential Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer
* Evaluate progression-free survival (PFS) in patients treated with sequential Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines
* Evaluate overall survival (OS) in patients treated with sequential Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer
* Evaluate the objective response rate (ORR) in patients treated with sequential Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer.
* Evaluate the disease control rate (DCR) in patients treated with Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX in patients with borderline resectable pancreatic cancer and locally advanced unresectable pancreatic cancer.

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

Primary outcomes:
measure: R0 Resection Rate - Borderline Resectable Prostate Cancer Participants
timeFrame: 9 months
measure: R0 Resection Rate - Locally Advanced Prostate Cancer Participants
timeFrame: 9 months
Secondary outcomes:
measure: Incidences of Adverse Events
timeFrame: Up to 1 year after completion of study intervention
measure: Number of Participants to Complete Study Intervention
timeFrame: 9 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 1 year after completion of study intervention
measure: Overall Survival (OS)
timeFrame: Up to 1 year after completion of study intervention
measure: Tumor Response
timeFrame: Up to 1 year after completion of study intervention
measure: Treatment Response
timeFrame: Up to 1 year after completion of study intervention
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Ravi K Paluri, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: