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Study of Gemcitabine and Abraxane for Pancreas Cancer

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ClinicalTrials.gov Identifier: NCT02242409
Recruitment Status : Terminated (Testing of combination no longer relevant)
First Posted : September 17, 2014
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Brief Summary:
A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine and Abraxane Phase 2

Detailed Description:
This is an open label Phase II study to evaluate the clinical activity of the combination of gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The hypothesis is that this combination will have a 4-month progression free survival of 70% or higher.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer
Study Start Date : September 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Gemcitabine/abraxane
Gemcitabine and Abraxane
Drug: Gemcitabine and Abraxane
Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
Other Names:
  • Gemzar
  • nanoparticle-bound paclitaxel
  • Nab-paclitaxel




Primary Outcome Measures :
  1. 4 month progression free survival [ Time Frame: 2.5 years ]
    The proportion of patients at 4 months from study entry with progression or death


Secondary Outcome Measures :
  1. Disease control rate [ Time Frame: 2.5 years ]
    Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria

  2. Progression Free Survival [ Time Frame: 2.5 years ]
    The time in days from study entry until progression or death

  3. Overall Survival [ Time Frame: 3 years ]
    The time in days from study entry until death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed metastatic adenocarcinoma of the pancreas
  • Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease
  • Radiographically measurable or evaluable disease
  • Age >/= 18 years
  • ECOG performance status 0-2
  • Adequate hepatic, bone marrow and renal function

Exclusion Criteria:

  • Prior gemcitabine-based chemotherapy in the first line setting
  • No active severe infection, or known chronic infection with HIV or hepatitis B virus
  • No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
  • No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception
  • Patients with known CNS metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel
  • Anticipated patient survival under 2 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242409


Locations
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United States, District of Columbia
Georgetown Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Michael Pishvaian, MD PhD Georgetown University

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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02242409     History of Changes
Other Study ID Numbers: LCCC 2013-0138
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Keywords provided by Georgetown University:
Metastatic pancreatic cancer
Second Line treatment
Gemcitabine
Nab-paclitaxel
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs