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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
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.
Details
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | WITHDRAWN |
| Start date | 2014-06 |
Conditions
- Chemotherapeutic Agent Toxicity
- Lung Cancer
Interventions
- Carboplatin
- Docetaxel
- Anvirzel
- Questionnaires
Primary outcomes
- Maximum Tolerated Dose (MTD) of sublingual (SL) dosing of Anvirzel in combination with chemotherapy — 21 Day Cycle
- Pharmacokinetics of carboplatin and docetaxel when administered concurrently with SL Anvirzel — 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