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Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer

ConditionsMetastatic Pancreatic AdenocarcinomaStage IV Pancreatic Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnne Noonan

About this trial

This phase II trial studies how well a biologically optimized infusion schedule of gemcitabine and nab-paclitaxel works in treating patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Altering the timing of the nab-paclitaxel infusion may improve response in patients with pancreatic cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Gemcitabine

    Drug

    Given IV

  • Nab-paclitaxel

    Drug

    Given IV

Treatment groups

67 Participants
are divided into 1 treatment group
Group A: Treatment (gemcitabine, nab-paclitaxel)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

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).

Time frame
Up to 2 years

Secondary outcomes

1

Incidence of adverse events (AEs)

AEs will be assessed by Common Terminology Criteria for Adverse Events version 5.0 of optimized infusion schedule of gemcitabine plus nab-paclitaxel. Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. All patients who have received at least one dose of the therapeutic agents will be evaluable for toxicity and tolerability.

Time frame
Up to 2 years
2

Disease control rate

Disease control rate is calculated as the proportion of patients who achieve a response and stable disease to therapy divided by the total number of evaluable patients. Disease control rate will be calculated along with corresponding 95% binomial CIs (assuming that the number of patients who respond is binomially distributed).

Time frame
Up to 2 years
3

Relative dose intensity

Relative dose intensity is calculated as the ratio of "delivered" to the "planned" dose over the period of therapy and will be summarized using descriptive statistics.

Time frame
Up to 2 years
4

Progression-free survival (PFS)

PFS will initially be modeled using Kaplan-Meier methods, resulting in median survival times with 95% CI, assuming sufficient events have occurred.

Time frame
From initiation of therapy to documented progression or death without progression, assessed up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anne Noonan

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov
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