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| ID | Type | Description | Link |
|---|---|---|---|
| MDA-2011-0147 | |||
| CDR0000728644 | Other Identifier | NCI Clinical Trials | |
| NCI-2012-00709 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Nerium Biotechnology | UNKNOWN |
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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.
Study Drug Administration:
If you are eligible and agree to take part in the study, you will be assigned to a dose level of nerium oleander based on when you join this study. Up to 5 dose levels of nerium oleander will be tested. At least 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of nerium oleander is found.
You will take nerium oleander by mouth by placing it under your tongue. You should hold the nerium oleander under your tongue for 3 minutes before swallowing. It is very important for you to hold the nerium oleander under your tongue for 3 full minutes. Holding it under your tongue for 3 minutes before swallowing helps your body to take in the highest amount of the drug that you can receive. If you hold the nerium oleander under your tongue for less than 3 minutes, your body will not receive as much of the study drug and may not possibly benefit as much. You will take nerium oleander 3 times a day while participating in this study. Nerium oleander should be taken on an empty stomach or at least 15 minutes before any large meal, to help your body take in as much of the drug as possible.
Study Visits:
Each of your chemotherapy cycles are 21 days.
Each week while on study, you will complete the questionnaire about any symptoms you may be having. It should take about 5 minutes to complete it each time.
Cycle 1:
On Day -7 (7 days before you start chemotherapy):
On Day -6, blood (about 2 teaspoons each time) will be drawn 1 time for PK testing.
On Day 1 (the day you start chemotherapy):
On Day 2:
On Day 8 (+/- 2 days):
On Day 1 of Cycles 2-3:
On Day 1 of Cycle 4:
On Day 2 of Cycle 4:
On Day 8 and Day 21 of Cycle 4 (+/- 2 days):
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest or up to 4 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visit.
End-of-Dosing Visit:
After your last dose of study drug, you will return to the clinic. The following tests and procedures will be performed:
Follow-Up Visit:
About 30 days after your last dose of study drug, the following tests and procedures will be performed:
This is an investigational study. Nerium oleander is not FDA approved or commercially available. Its use in this study is considered investigational.
Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anvirzel + Carboplatin + Docetaxel | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | AUC 6 by vein 7 days after Anvirzel administration in a 21 dayc cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-inflammatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy | Up to four 21 day cycles (84 days) | |
| Immunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy | Up to four 21 day cycles (84 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard T. Lee, MD, FACP | M.D. Anderson Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| The University of Texas MD Anderson Cancer Center Official Website | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| C430926 | Anvirzel |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| Docetaxel | Drug | 75 mg/m2 by vein 7 days after Anvirzel administration in a 21 day cycle. |
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| Anvirzel | Drug | 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 |
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| Questionnaires | Behavioral | 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. |
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| 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) |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |