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New treatment option for Metastatic Pancreatic Adenocarcinoma
Official title Biologically Optimized Infusion Schedule of Gemcitabine and Nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer
ClinicalTrials.gov ID: NCT04115163
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for metastatic pancreatic adenocarcinoma.
Also referred to as dFdC, dFdCyd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant has definitive histologically or cytologically confirmed adenocarcinoma of the pancreas. The definitive diagnosis of metastatic...
- Patient has one or more metastatic tumors measurable by computed tomography (CT) scan (or magnetic resonance imaging [MRI], if patient is allergic to...
- 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...
- The patient must agree to use a method of contraception considered highly effective by the investigator during the period of administration of study...
You likely can't join if
- Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no...
- 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...
- 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 is unwilling or unable to comply with study procedures
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
- Patient is unwilling or unable to comply with study procedures
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.