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
- 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.
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Maximum Tolerated Dose (MTD) of sublingual (SL) dosing of Anvirzel in combination with chemotherapy
21 Day Cycle
Richard T. Lee, MD, FACP
M.D. Anderson Cancer Center
United States: Food and Drug Administration