Oleandrin (Nerium Oleander) in Combination With Carboplatin and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
RATIONALE: Nerium oleander (Anvirzel or oleandrin) may reduce the side effects caused by chemotherapy, such as carboplatin and docetaxel.
PURPOSE: This phase I trial studies the side effects and the best dose of Anvirzel in combination with carboplatin and docetaxel in treating patients with advanced non-small cell lung cancer.
Chemotherapeutic Agent Toxicity
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|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|
- Maximum Tolerated Dose (MTD) of sublingual (SL) dosing of Anvirzel in combination with chemotherapy [ Time Frame: 21 Day Cycle ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of carboplatin and docetaxel when administered concurrently with SL Anvirzel [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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
- Anti-inflammatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy [ Time Frame: Up to four 21 day cycles (84 days) ] [ Designated as safety issue: No ]
- Immunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy [ Time Frame: Up to four 21 day cycles (84 days) ] [ Designated as safety issue: No ]
- Symptoms and quality-of-life outcomes based on MDASI-LC and SF-12 scores [ Time Frame: Up to four 21 day cycles (84 days) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Oleandrin + Carboplatin + Docetaxel
Oleander assigned dose three times per day beginning 7 days prior to starting chemotherapy with area under curve (AUC) of 5 for Carboplatin and 75 mg/m^2 for Docetaxel in 21 day cycle.
Other Name: ParaplatinDrug: Docetaxel
Other Name: TaxotereDrug: Oleandrin
Assigned dose three times per day beginning 7 days prior to starting chemotherapy.
- 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.
|Principal Investigator:||Richard T. Lee, MD, FACP||M.D. Anderson Cancer Center|