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Sublingual Anvirzel in Advance Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT01562301
Recruitment Status : Withdrawn
First Posted : March 23, 2012
Last Update Posted : June 8, 2015
National Cancer Institute (NCI)
Nerium Biotechnology
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of Anvirzel (Nerium Oleander) that can be given to lung cancer patients receiving standard therapy with carboplatin and docetaxel. Researchers also want to learn what effect Nerium Oleander may have in combination with carboplatin and docetaxel.

Condition or disease Intervention/treatment Phase
Chemotherapeutic Agent Toxicity Lung Cancer Drug: Carboplatin Drug: Docetaxel Drug: Anvirzel Behavioral: Questionnaires Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2014
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Anvirzel + Carboplatin + Docetaxel
Anvirzel administered sublingually. A total of five dose cohorts evaluated (6, 12, 24, 36, 48 mg/m2/day; SL divided into 3 doses given every 8 hrs) with 3 patients per cohort. Patients receive the assigned dose (2, 4, 8, 12, or 16 mg/m2) of Anvirzel three times a day throughout each cycle for a total of 4 cycles of chemotherapy. Cycles occur every 21 days. Patients start with an AUC of 6 for Carboplatin and 75mg/m2 for docetaxel, and on subsequent cycles, modifications at the discretion of the treating team. Questionnaire completion regarding physical and mental at baseline, 7 days before chemotherapy, day 1 of chemotherapy, day 1 of cycles 2, 3, and 4, and at end of dosing visit.
Drug: Carboplatin
AUC 6 by vein 7 days after Anvirzel administration in a 21 dayc cycle.
Other Name: Paraplatin

Drug: Docetaxel
75 mg/m2 by vein 7 days after Anvirzel administration in a 21 day cycle.
Other Name: Taxotere

Drug: Anvirzel

Starting Cohort Dose: 6 mg/m2 given 3 times a day administered sublingually for a 21 day cycle.

Expansion Cohort Starting Dose: Maximum tolerated dose from

Other Name: Nerium oleander

Behavioral: Questionnaires
Questionnaire completion regarding physical and mental at baseline, 7 days before chemotherapy, day 1 of chemotherapy, day 1 of cycles 2, 3, and 4, and at end of dosing visit.
Other Name: Surveys

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of sublingual (SL) dosing of Anvirzel in combination with chemotherapy [ Time Frame: 21 Day Cycle ]
  2. Pharmacokinetics of carboplatin and docetaxel when administered concurrently with SL Anvirzel [ Time Frame: 24 hours ]
    Pharmacokinetic studies evaluate plasma concentrations over a 24 hour period prior to administration of chemotherapy, using high performance liquid chromatographic and electron ion-spray mass spectrometry

Secondary Outcome Measures :
  1. Anti-inflammatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy [ Time Frame: Up to four 21 day cycles (84 days) ]
  2. Immunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy [ Time Frame: Up to four 21 day cycles (84 days) ]
  3. Symptoms and quality-of-life outcomes based on MDASI-LC and SF-12 scores [ Time Frame: Up to four 21 day cycles (84 days) ]
  4. Grade 3-4 toxicities at each course according to NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 [ Time Frame: Up to four 21 day cycles (84 days) ]

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

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed diagnosed advanced non-small cell lung cancer (Stage IIIB and IV) and be scheduled to receive four cycles of carboplatin and docetaxel chemotherapy.
  2. Newly diagnosed or previously treated patient with NSCLC. Previously treated patients are allowed to have any previous chemotherapy for the treatment of NSCLC.
  3. Age >18 years
  4. ECOG performance status < or =2 (Karnofsky > or = 60%)
  5. Life expectancy of greater than 6 months
  6. Patients must have normal organ and marrow function as defined below: - leukocytes > or = 3,000/mcL - absolute neutrophil count > or = 1,500/mcL - platelets > or = 100,000/mcL - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) < or = 2.5 X institutional upper limit of normal - creatinine within normal institutional limits OR - creatinine clearance > or = 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  7. Negative serum or urine pregnancy test in women of child-bearing potential
  8. Scheduled to begin carboplatin and docetaxel chemotherapy in the next 30 days
  9. The effects of Anvirzel on the developing human fetus are unknown. For this reason, 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  10. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  1. Patients receiving any other investigational agents
  2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cardiac glycosides
  3. Patients receiving any medications or substances that are inhibitors or inducers of CYP 3A4 are ineligible
  4. 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
  5. Pregnant or breastfeeding women
  6. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Anvirzel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  7. Uncontrolled or significant cardiovascular disease, including: • Myocardial infarction within 6 months • Uncontrolled angina within 6 months • Newly diagnosed congestive heart failure within 6 months, defined as NYHC-II or currently uncontrolled congestive heart failure • 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 (> 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 • Heart rate < 50 beats/minute or sustained heart rate > 110 on pre-entry electrocardiogram • Newly diagnosed atrial fibrillation within 6 months or currently uncontrolled atrial fibrillation • Uncontrolled hypertension defined as sustained blood pressure of >/= 140/90mm Hg
  8. Current use of a pacemaker
  9. Patients using or scheduled to use bevacizumab during study period
  10. Current use of cardiac glycoside

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): NCT01562301

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Nerium Biotechnology
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Principal Investigator: Richard T. Lee, MD, FACP M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01562301    
Other Study ID Numbers: 2011-0147
CDR0000728644 ( Other Identifier: NCI Clinical Trials )
NCI-2012-00709 ( Registry Identifier: NCI CTRP )
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by M.D. Anderson Cancer Center:
chemotherapeutic agent toxicity
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
nerium oleander
Advanced Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action