Optimized Gemcitabine and Nab-Paclitaxel for Metastatic Pancreatic Cancer
This study is looking at a new way to give two chemotherapy drugs, gemcitabine and nab-paclitaxel, to people with pancreatic cancer that has spread (metastatic). Researchers are changing the timing of the nab-paclitaxel infusion to see if it works better. These drugs aim to stop cancer cells from growing, dividing, or spreading. The main goal is to see how many patients respond to this new schedule. You may be able to join if you are 18 or older and have pancreatic adenocarcinoma that has spread. The study plans to enroll 67 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a single-arm study, meaning all participants receive the same treatment, and plans to enroll 67 participants.
- What's involved
- You would receive gemcitabine and nab-paclitaxel intravenously (IV) on specific days every 28 days. This treatment continues as long as your cancer doesn't worsen or side effects are manageable.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you will have monthly follow-up visits for 3 months, then every 3 months afterward. The overall response rate will be measured for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04115163
Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentAnne NoonanInvestigator-initiated
~67 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:GemcitabineNab-paclitaxel
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR)
Measured over Up to 2 years
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Laith Abushahin, MBBS · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participant has definitive histologically or cytologically confirmed adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Participants with islet cell neoplasms are excluded
Patient has one or more metastatic tumors measurable by computed tomography (CT) scan (or magnetic resonance imaging \[MRI\], if patient is allergic to CT contrast media or if the tumor is difficult to delineate on CT scan) as defined by RECIST 1.1 criteria
Non-pregnant and non-lactating
If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test beta-human chorionic gonadotropin (beta-hCG) documented 72 hours prior to the first administration of study drug
The patient must agree to use a method of contraception considered highly effective by the investigator during the period of administration of study drug and after the end of treatment for an additional 3 months. Adequate birth control methods are defined below
Women will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or if they are post-menopausal (defined as absence of menses for at least 1 year). Sexually active men and women of childbearing potential who are sexually active and not willing to use a highly effective method of birth control during the trial and for at least three months after will be considered ineligible for the trial. A highly effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner. In the event that local regulations require additional restrictions to the above definition, the patient information will specify the acceptable contraceptive methods
Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic pancreatic cancer. Prior adjuvant treatment is allowed as long as the last chemotherapy was \> 6 months ago. Prior use of 5-fluorouracil (5-FU) or gemcitabine administered as a radiation sensitizer or in the adjuvant setting is allowed, provided at least 2 month have elapsed since completion of the last dose and no lingering significant toxicities are present. Prior radiation is allowed as long as the planned lesion(s) to be measured were not previously radiated
Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (obtained =\< 14 days prior to randomization)
Platelet count \>= 100,000/mm\^3 (100 x 10\^9/L) (obtained =\< 14 days prior to randomization)
Hemoglobin (Hgb) \>= 9 g/dL (obtained =\< 14 days prior to randomization)
Aspartate transaminase (AST), serum glutamic-oxaloacetic transaminase (SGOT), alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT) =\< 2.5 x upper limit of normal range (ULN), unless liver metastases are clearly present, then =\< 5 x ULN is allowed (obtained =\< 14 days prior to randomization)
Total bilirubin =\< 2 x ULN (obtained =\< 14 days prior to randomization)
Patient has Karnofsky performance status (KPS) \>= 60 or Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Patient has been informed about the nature of the study, has agreed to participate in the study, and signed the informed consent form (ICF) prior to participation in any study-related activities
Exclusion
Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart)
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
Patient has known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Patient has a history of allergy or hypersensitivity to any of the study drugs or any of their excipients
Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity based on the assessment of the enrolling physician
Patient is unwilling or unable to comply with study procedures
What this trial measures
- Overall response rate (ORR)Up to 2 years
ORR will be assessed by Response Evaluation Criteria in Solid Tumors 1.1 in patients with advanced pancreatic adenocarcinoma to receive optimized infusion schedule of gemcitabine plus nab-paclitaxel. The ORR will be calculated as the proportion of patients who achieve a response to therapy divided by the total number of evaluable patients. All evaluable patients will be included in calculating the ORR for the study along with corresponding 95% binomial confidence intervals (CIs) (assuming that the number of patients who respond is binomially distributed).