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Gemcitabine With Curcumin for Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
curcumin (+ gemcitabine)
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring carcinoma, pancreas, gemcitabine, curcumin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: locally advanced or metastatic adenocarcinoma of the pancreas no prior chemotherapy performance status 0-2 adequate hematology and chemistry Exclusion Criteria: serious concurrent medical condition

Sites / Locations

    Outcomes

    Primary Outcome Measures

    time to tumor progression

    Secondary Outcome Measures

    response rate
    survival
    clinical benefit
    toxicity

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    September 21, 2010
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00192842
    Brief Title
    Gemcitabine With Curcumin for Pancreatic Cancer
    Official Title
    Phase II Trial of Gemcitabine and Curcumin in Patients With Advanced Pancreatic Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study hypotheasis is that curcumin, a natural compound with a potent antiproliferative effect, can improve the efficacy of the standard chemotherapy gemcitabine in patients with advanced pancreatic cancer. That is why the patients are given a daily oral dose of 8 gr of curcumin along the chemotherapeutic protocol of weekly gemcitabine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Cancer
    Keywords
    carcinoma, pancreas, gemcitabine, curcumin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    curcumin (+ gemcitabine)
    Primary Outcome Measure Information:
    Title
    time to tumor progression
    Secondary Outcome Measure Information:
    Title
    response rate
    Title
    survival
    Title
    clinical benefit
    Title
    toxicity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: locally advanced or metastatic adenocarcinoma of the pancreas no prior chemotherapy performance status 0-2 adequate hematology and chemistry Exclusion Criteria: serious concurrent medical condition
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ron Epelbaum, MD
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Gemcitabine With Curcumin for Pancreatic Cancer

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