Sublingual Anvirzel in Advance Non-Small Cell Lung Cancer (NSCLC)
|ClinicalTrials.gov Identifier: NCT01562301|
Recruitment Status : Withdrawn
First Posted : March 23, 2012
Last Update Posted : June 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapeutic Agent Toxicity Lung Cancer||Drug: Carboplatin Drug: Docetaxel Drug: Anvirzel Behavioral: Questionnaires||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
AUC 6 by vein 7 days after Anvirzel administration in a 21 dayc cycle.
Other Name: Paraplatin
75 mg/m2 by vein 7 days after Anvirzel administration in a 21 day cycle.
Other Name: Taxotere
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
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
- Maximum Tolerated Dose (MTD) of sublingual (SL) dosing of Anvirzel in combination with chemotherapy [ Time Frame: 21 Day Cycle ]
- 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
- Anti-inflammatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy [ Time Frame: Up to four 21 day cycles (84 days) ]
- Immunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy [ Time Frame: Up to four 21 day cycles (84 days) ]
- Symptoms and quality-of-life outcomes based on MDASI-LC and SF-12 scores [ Time Frame: Up to four 21 day cycles (84 days) ]
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562301
|Principal Investigator:||Richard T. Lee, MD, FACP||M.D. Anderson Cancer Center|