Actively Recruiting
A Pilot Study of Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel in Metastatic Pancreatic Adenocarcinoma
Led by Anne Noonan · Updated on 2026-02-11
67
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new infusion schedule of the chemotherapy drugs gemcitabine and nab-paclitaxel for adults with metastatic pancreatic cancer. This phase II trial studies how changing the timing of these drugs may affect tumor response. The study aims to report the overall response rate, side effects, disease control, dose intensity, survival rates, and explore biomarkers in this patient population. Participants receive gemcitabine intravenously over 30 minutes on days 1 and 15, and nab-paclitaxel intravenously over 30 minutes on days 3 and 17. Each treatment cycle repeats every 28 days as long as the disease does not progress and side effects are acceptable. After treatment ends, patients have monthly follow-up visits for 3 months, then every 3 months thereafter. During the study, participants will have imaging scans to measure tumor response, blood tests to monitor side effects and drug dosing, and evaluations of overall health and survival. Researchers will track adverse events and disease progression for up to 2 years. The study includes regular assessments to ensure safety and to collect data on how well the treatment schedule controls cancer growth.
CONDITIONS
Brief Title
Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has definitive histologically or cytologically confirmed adenocarcinoma of the pancreas
- Patient has one or more metastatic tumors measurable by CT scan or MRI as defined by RECIST 1.1 criteria
- Non-pregnant and non-lactating
- Female patients of child-bearing potential must have a negative pregnancy test before treatment and agree to use highly effective contraception during and for 3 months after treatment
- Patients must have received no previous chemotherapy or investigational therapy for metastatic pancreatic cancer; prior adjuvant treatment allowed if last chemotherapy was more than 6 months ago
- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L within 14 days prior to randomization
- Platelet count greater than or equal to 100,000/mm^3 within 14 days prior to randomization
- Hemoglobin greater than or equal to 9 g/dL within 14 days prior to randomization
- Liver enzymes (AST/ALT) less than or equal to 2.5 times upper limit of normal (ULN), or less than or equal to 5 times ULN if liver metastases present, within 14 days prior to randomization
- Total bilirubin less than or equal to 2 times ULN within 14 days prior to randomization
- Karnofsky performance status of 60 or higher or ECOG performance status of 0-2
- Patient has signed informed consent form prior to participation
You will not qualify if you...
- Patient has known brain metastases unless previously treated and well-controlled for at least 3 months
- Patient has active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
- Patient has known active infection with HIV, hepatitis B, or hepatitis C unless HIV is well-controlled with undetectable viral load
- Patient has allergy or hypersensitivity to study drugs or their components
- Patient has serious medical risk factors or psychiatric disorders compromising safety or data integrity
- Patient is unwilling or unable to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive gemcitabine intravenously over 30 minutes on days 1 and 15 and nab-paclitaxel intravenously over 30 minutes on days 3 and 17. These cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Multiple visits every cycle for drug infusions
Duration - Up to 2 years
Participants are followed up monthly for 3 months and then every 3 months thereafter to monitor overall survival and disease status.
Monthly visits for 3 months, then visits every 3 months
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
D
Danielle Trunzo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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