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Clinical Trial Record

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Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer

2013-02

2015-01

2015-01

15

Study Overview

Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer

To determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

This study will help determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly, opposed to a weekly, dosing schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cancer.

  • Pancreatic Carcinoma Non-resectable
  • Stage IV Pancreatic Cancer
  • DRUG: Gemcitabine
  • DRUG: nab-Paclitaxel
  • WRMC 12-25

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2013-02-15  

2017-09-27  

2018-01-11  

2013-05-09  

2017-10-29  

2018-02-07  

2013-05-10  

2017-12-04  

2018-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Gemcitabine and nab-Paclitaxel

Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days

DRUG: Gemcitabine

  • Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion

DRUG: nab-Paclitaxel

  • Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion
Primary Outcome MeasuresMeasure DescriptionTime Frame
Overall Survival Based on Toxicity Profile of Adverse Events.Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-PaclitaxelOne year
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Progression Free Survival TimeDetermine progression free survival time with this regimenOne year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma. 2. Patient has one or more radiographically measurable tumor. 3. Patients may have received prior adjuvant chemotherapy or radiation therapy (RT). 4. Age ≥ 18 years. 5. Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study. 6. ECOG performance status 0 - 2 and an expected survival of at least 3 months. 7. Acceptable hematological parameters within 2 weeks of commencing study therapy as follows:

  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin (Hgb) ≥ 9g/dl 8. Patients with adequate organ function as measured by:

    • A. Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
    B. Hepatic: Bilirubin ≤ 2.0 mg/ and ALT and AST ≤ 1.5x the upper limit of normal.
    C. Renal: Creatinine ≤ 1.5 mg/dl and no other chronic kidney disease. 9. Women must meet one of the following criteria:

  • Post-menopausal for at least one year
  • Surgically incapable of child-bearing
  • Utilizing a reliable form of contraception for the duration of study participation. Women of child-bearing potential must have a negative serum β-HCG within 7 days of study drug administration.

    • Exclusion Criteria:
    1. Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting. 2. Previous use of any chemotherapy or radiation therapy for metastatic disease. 3. 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). 4. Other significant active or chronic infection. 5. History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia. 6. Pregnant or nursing females. 7. 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. 8. Major surgery, other than diagnostic surgery within 4 weeks of study entry. 9. Patient requires a legal authorized representative for consenting.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Madappa Kundranda, MD, PhD, Western Regional Medical Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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    The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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