Sublingual Anvirzel in Advance Non-Small Cell Lung Cancer (NSCLC)

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Nerium Biotechnology
• Treatments: Carboplatin; Docetaxel

Criteria

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed diagnosed advanced non-small cell lung cancer (Stage IIIB and IV) and be scheduled to receive four cycles of carboplatin and docetaxel chemotherapy.

2. Newly diagnosed or previously treated patient with NSCLC. Previously treated patients are allowed to have any previous chemotherapy for the treatment of NSCLC.

3. Age >18 years

4. ECOG performance status < or =2 (Karnofsky > or = 60%)

5. Life expectancy of greater than 6 months

6. Patients must have normal organ and marrow function as defined below: - leukocytes > or = 3,000/mcL - absolute neutrophil count > or = 1,500/mcL - platelets > or = 100,000/mcL - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) < or = 2.5 X institutional upper limit of normal - creatinine within normal institutional limits OR - creatinine clearance > or = 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

7. Negative serum or urine pregnancy test in women of child-bearing potential

8. Scheduled to begin carboplatin and docetaxel chemotherapy in the next 30 days

9. The effects of Anvirzel on the developing human fetus are unknown. For this reason, 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

10. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients receiving any other investigational agents

2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cardiac glycosides

3. Patients receiving any medications or substances that are inhibitors or inducers of CYP 3A4 are ineligible

4. 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

5. Pregnant or breastfeeding women

6. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Anvirzel. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.

7. Uncontrolled or significant cardiovascular disease, including: • Myocardial infarction within 6 months • Uncontrolled angina within 6 months • Newly diagnosed congestive heart failure within 6 months, defined as NYHC-II or currently uncontrolled congestive heart failure • 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 QTc interval on pre-entry electrocardiogram (> 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 • Heart rate < 50 beats/minute or sustained heart rate > 110 on pre-entry electrocardiogram • Newly diagnosed atrial fibrillation within 6 months or currently uncontrolled atrial fibrillation • Uncontrolled hypertension defined as sustained blood pressure of >/= 140/90mm Hg

8. Current use of a pacemaker

9. Patients using or scheduled to use bevacizumab during study period

10. Current use of cardiac glycoside