Sublingual Anvirzel in Advance Non-Small Cell Lung Cancer (NSCLC)
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|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Recruitment Status : Withdrawn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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|