Sponsor study identifier
Secondary identifiers
OTHER · NCI Clinical Trials
REGISTRY · NCI CTRP
interventional
0
0 countries
N/A
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedThe 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 21, 2012
Actual (reported)March 23, 2012
Actual (reported)June 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
24 hours
Anti-inflammatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy
Up to four 21 day cycles (84 days)
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.
75 mg/m2 by vein 7 days after Anvirzel administration in a 21 day cycle.
Richard T. Lee, MD, FACP
M.D. Anderson Cancer Center
0 participants (actual enrollment reported by the registry).
First Submitted
March 21, 2012
First Posted
March 23, 2012
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Immunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy
Up to four 21 day cycles (84 days)
Symptoms and quality-of-life outcomes based on MDASI-LC and SF-12 scores
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
Up to four 21 day cycles (84 days)
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 8, 2015
Record last verified: 2015-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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