Oleandrin (Nerium Oleander) in Combination With Carboplatin and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
This study is not yet open for participant recruitment.
Verified November 2012 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01562301
First received: March 21, 2012
Last updated: November 20, 2012
Last verified: November 2012
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Purpose
RATIONALE: Nerium oleander (Anvirzel or oleandrin) may reduce the side effects caused by chemotherapy, such as carboplatin and docetaxel.
PURPOSE: This phase I trial studies the side effects and the best dose of Anvirzel in combination with carboplatin and docetaxel in treating patients with advanced non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapeutic Agent Toxicity Lung Cancer |
Drug: Carboplatin Drug: Docetaxel Drug: Oleandrin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) of sublingual (SL) dosing of Anvirzel in combination with chemotherapy [ Time Frame: 21 Day Cycle ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of carboplatin and docetaxel when administered concurrently with SL Anvirzel [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Anti-inflammatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy [ Time Frame: Up to four 21 day cycles (84 days) ] [ Designated as safety issue: No ]
- Immunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy [ Time Frame: Up to four 21 day cycles (84 days) ] [ Designated as safety issue: No ]
- Symptoms and quality-of-life outcomes based on MDASI-LC and SF-12 scores [ Time Frame: Up to four 21 day cycles (84 days) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2013 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Oleandrin + Carboplatin + Docetaxel
Oleander assigned dose three times per day beginning 7 days prior to starting chemotherapy with area under curve (AUC) of 5 for Carboplatin and 75 mg/m^2 for Docetaxel in 21 day cycle.
|
Drug: Carboplatin
Other Name: Paraplatin
Drug: Docetaxel
Other Name: Taxotere
Drug: Oleandrin
Assigned dose three times per day beginning 7 days prior to starting chemotherapy.
Other Names:
|
Detailed Description:
OBJECTIVES:
Primary Objective
- To determine the maximum-tolerated dose (MTD) of sublingual (SL) dosing of oleandrin (nerium oleander; Anvirzel) in patients with advanced non-small cell lung cancer (NSCLC) treated with chemotherapy.
- To evaluate the pharmacokinetics of carboplatin and docetaxel when administered concurrently with SL Anvirzel.
Secondary Objective
- To evaluate the anti-inflammatory and immunomodulatory effects of SL Anvirzel during carboplatin and docetaxel chemotherapy in patients with advanced NSCLC.
- To evaluate symptoms and quality-of-life outcomes, the incidence of grade 3-4 toxicities, dose reductions, dose delays, and completion of scheduled carboplatin and docetaxel chemotherapy with SL Anvirzel in patients with advanced NSCLC.
OUTLINE: This is a dose-escalation study of oleandrin (nerium oleander extract).
Patients receive oleandrin sublingually (SL) 3 times daily (TID) on days -7 to 0 of course 1 and then throughout each course of carboplatin IV and docetaxel IV. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients complete the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) and the quality-of-life (SF-12) questionnaires at baseline and periodically during treatment.
Plasma and peripheral blood mononuclear cell samples are collected at baseline and periodically during treatment for biomarker, pharmacokinetic, and pharmacodynamic studies.
After completion of study treatment, patients are followed up for 4 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Patients must have histologically or cytologically confirmed diagnosed non-small cell lung cancer (NSCLC) and be scheduled to receive four courses of carboplatin and docetaxel chemotherapy
- Scheduled to begin carboplatin and docetaxel chemotherapy in the next 30 days
- Newly diagnosed or previously treated patient with NSCLC; previously treated patients are allowed to have any previous chemotherapy for the treatment of NSCLC
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
- Life expectancy of greater than 6 months
- Leukocytes ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 times institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min
- Negative serum or urine pregnancy test in women of child-bearing potential
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- Ability to understand and the willingness to sign a written informed consent document
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cardiac glycosides
- No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Not pregnant or breastfeeding
- HIV-positive patients on combination antiretroviral therapy are ineligible
No uncontrolled or significant cardiovascular disease, including:
- A myocardial infarction within 6 months
- Uncontrolled angina within 6 months
- Congestive heart failure within 6 months, defined as New York Heart Classification II (NYHC-II)
- Diagnosed or suspected congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes); prolonged corrected QT interval (QTc) interval on pre-entry electrocardiogram (EKG) (> 450 msec); if the automated reading is prolonged (i.e., > 450 msec), the EKG should be manually over-read
- Any history of second or third degree heart block (may be eligible if currently have a pacemaker)
- Heart rate < 50 beats/minute OR sustained heart rate > 110 beats/minute on pre-entry electrocardiogram (EKG or ECG)
- Uncontrolled hypertension
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No patients receiving any other investigational agents
- Patients receiving any medications or substances that are inhibitors or inducers of CYP 3A4 are ineligible
- No patients using or scheduled to use bevacizumab during study period
- No current use of cardiac glycoside
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01562301 History of Changes |
| Other Study ID Numbers: | 2011-0147, MDA-2011-0147, CDR0000728644 |
| Study First Received: | March 21, 2012 |
| Last Updated: | November 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
chemotherapeutic agent toxicity recurrent non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer carboplatin |
docetaxel Anvirzel nerium oleander Advanced Non-Small Cell Lung Cancer NSCLC |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Docetaxel Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013