Anvirzel

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  • #62002
    marions
    Moderator

    Narider…thank you so very much for bringing this clinical trial to our attention.
    Another way to do this valuable service for our members might be by enclosing the link:
    http://clinicaltrials.gov/ct2/show/NCT01562301

    Thanks again,
    Hugs,
    Marion

    #6952
    narindersingh
    Spectator

    Phase I Study of Oleandrin (Nerium Oleander Extract) in Combination With Carboplatin and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
    Alternate Title
    Basic Trial Information
    Objectives
    Entry Criteria
    Expected Enrollment
    Outcomes
    Outline
    Trial Contact Information
    Registry Information

    Alternate Title

    Oleandrin (Nerium Oleander) in Combination With Carboplatin and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

    Basic Trial Information

    Phase Type Status Age Sponsor Protocol IDs
    Phase I Biomarker/Laboratory analysis, Supportive care Approved-not yet active 18 and over NCI MDA-2011-0147
    2011-0147, NCT01562301
    Objectives

    Primary Objective

    I.To determine the maximum-tolerated dose (MTD) of sublingual (SL) dosing of oleandrin (nerium oleander; Anvirzel) in patients with advanced non-small cell lung cancer (NSCLC) treated with chemotherapy.
    II.To evaluate the pharmacokinetics of carboplatin and docetaxel when administered concurrently with SL Anvirzel.
    Secondary Objective

    I.To evaluate the anti-inflammatory and immunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy in patients with advanced NSCLC.
    II.To evaluate symptoms and quality-of-life outcomes, the incidence of grade 3-4 toxicities, dose reductions, dose delays, and completion of scheduled carboplatin and docetaxel chemotherapy with SL Anvirzel in patients with advanced NSCLC.
    Entry Criteria

    Disease Characteristics:

    •Patients must have histologically or cytologically confirmed diagnosed non-small cell lung cancer (NSCLC) and be scheduled to receive four courses of carboplatin and docetaxel chemotherapyScheduled to begin carboplatin and docetaxel chemotherapy in the next 30 days

    •Newly diagnosed or previously treated patient with NSCLC; previously treated patients are allowed to have any previous chemotherapy for the treatment of NSCLC

    Prior/Concurrent Therapy:

    •See Disease Characteristics
    •No patients receiving any other investigational agents
    •Patients receiving any medications or substances that are inhibitors or inducers of CYP 3A4 are ineligible
    •No patients using or scheduled to use bevacizumab during study period
    •No current use of cardiac glycoside

    Patient Characteristics:

    •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
    •Life expectancy of greater than 6 months
    •Leukocytes ≥ 3,000/mcL
    •Absolute neutrophil count ≥ 1,500/mcL
    •Platelets ≥ 100,000/mcL
    •Total bilirubin within normal institutional limits
    •Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 times institutional upper limit of normal
    •Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min
    •Negative serum or urine pregnancy test in women of child-bearing potential
    •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
    •Ability to understand and the willingness to sign a written informed consent document
    •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cardiac glycosides
    •No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    •Not pregnant or breastfeeding
    •HIV-positive patients on combination antiretroviral therapy are ineligible
    •No uncontrolled or significant cardiovascular disease, including:A myocardial infarction within 6 months
    Uncontrolled angina within 6 months
    Congestive heart failure within 6 months, defined as New York Heart Classification II (NYHC-II)
    Diagnosed or suspected congenital long QT syndrome
    Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes); prolonged QTc interval on pre-entry electrocardiogram (EKG) (> 450 msec); if the automated reading is prolonged (i.e., > 450 msec), the EKG should be manually over-read
    Any history of second or third degree heart block (may be eligible if currently have a pacemaker)
    Heart rate < 50 beats/minute OR sustained heart rate > 110 beats/minute on pre-entry EKG
    Uncontrolled hypertension

    Expected Enrollment

    30Outcomes

    Primary Outcome(s)
    MTD of SL dosing of Anvirzel in combination with chemotherapy
    Pharmacokinetics of carboplatin and docetaxel when administered concurrently with SL Anvirzel

    Secondary Outcome(s)
    Anti-inflammatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy
    Immunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy
    Symptoms and quality-of-life outcomes based on MDASI-LC and SF-12 scores
    Grade 3-4 toxicities at each course according to NCI CTCAE version 4.0
    Dose reduction and delays at each course

    Outline

    This is a dose-escalation study of oleandrin (nerium oleander extract).

    Patients receive oleandrin sublingually (SL) 3 times daily (TID) on days -7 to 0 of course 1 and then throughout each course of carboplatin IV and docetaxel IV. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

    Patients complete the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) and the quality-of-life (SF-12) questionnaires at baseline and periodically during treatment.

    Plasma and peripheral blood mononuclear cell samples are collected at baseline and periodically during treatment for biomarker, pharmacokinetic, and pharmacodynamic studies.

    After completion of study treatment, patients are followed up for 4 weeks.

    Trial Contact Information

    Trial Lead Organizations

    M. D. Anderson Cancer Center at University of Texas

    Richard Lee, MD, FACP, Principal investigator Ph: 713-745-2889; 800-392-1611

    Registry Information

    Official Title A Phase I Study of the Combination of Carboplatin, Docetaxel, and Increasing Doses of Sublingual Anvirzel (Nerium Oleander) in Advance Non-Small Cell Lung Cancer

    Trial Start Date 2012-05-01 (estimated)

    Trial Completion Date 2013-05-01 (estimated)

    Registered in ClinicalTrials.gov NCT01562301

    Date Submitted to PDQ 2012-03-08

    Information Last Verified

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