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

January 11, 2018 updated by: Western Regional Medical Center

A Phase II Study Evaluating Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel in the First Line Treatment of Surgically Unresectable/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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Western Regional Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / 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
Other Names:
  • Gemzar
Drug: nab-Paclitaxel
Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion
Other Names:
  • Abraxane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Based on Toxicity Profile of Adverse Events.
Time Frame: One year
Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival Time
Time Frame: One year
Determine progression free survival time with this regimen
One year

Collaborators and Investigators

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

Sponsor

Western Regional Medical Center

Investigators

  • Principal Investigator: Madappa Kundranda, MD, PhD, Western Regional Medical Center

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 Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (ESTIMATE)

May 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRMC 12-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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