Know Cancer

forgot password

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

Phase 1
18 Years
Not Enrolling
Chemotherapeutic Agent Toxicity, Lung Cancer

Thank you

Trial Information

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


Primary Objective

- 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.

- To evaluate the pharmacokinetics of carboplatin and docetaxel when administered
concurrently with SL Anvirzel.

Secondary Objective

- To evaluate the anti-inflammatory and immunomodulatory effects of SL Anvirzel during
carboplatin and docetaxel chemotherapy in patients with advanced NSCLC.

- 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.

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.

Inclusion Criteria


- 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 chemotherapy

- Scheduled 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


- 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 corrected QT interval (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 electrocardiogram (EKG or ECG)

- Uncontrolled hypertension


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Maximum Tolerated Dose (MTD) of sublingual (SL) dosing of Anvirzel in combination with chemotherapy

Outcome Time Frame:

21 Day Cycle

Safety Issue:


Principal Investigator

Richard T. Lee, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

Related Keywords:

  • Chemotherapeutic Agent Toxicity
  • Lung Cancer
  • 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
  • carboplatin
  • docetaxel
  • Anvirzel
  • nerium oleander
  • Advanced Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms