A Study for Reducing Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer by Minocycline and Armodafinil

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Armodafinil; Minocycline; Modafinil

Criteria

Inclusion Criteria:

1. Patients with a pathologically proven diagnosis of NSCLC and consented to concurrent chemoradiation therapy at MD Anderson.

2. Patients > or =18 years old

3. Patients who will receive chemoradiation with platinum/taxane-based chemotherapy and with a total radiation dose of > 50 Gy, per treating physician's assessment

4. Patients who speak English or Spanish (due to the novel research and its complexity, we are only accruing English or Spanish-speaking patients to the protocol)

5. Patients must be willing and able to review, understand, and provide written consent before starting therapy

Exclusion Criteria:

1. Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions, as determined by the treating physician

2. Patients who are enrolled in other symptom management or treatment clinical trials

3. Patients currently taking methylphenidate and/or dextroamphetamine.

4. Patients with a history of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction as documented in the patient medical records

5. Patients with pre-existing psychosis or bipolar disorder.

6. Patients with pre-existing renal impairment: The screening cut off for serum creatinine >1.5 times upper limits of normal (ULN), according to MD Anderson testing standards, will be done by the oncologist to qualify for CXRT.

7. Patients with pre-existing hepatic impairment: The screening for total bilirubin >1.5 times ULN will be done by the oncologist to qualify for CXRT. The screening for > 2 times the upper limit of normal hepatotoxicity, alkaline phosphatase (ALP) and alanine aminotransferase (ALT) (and aspartate aminotransferase [AST] if it is ordered and available in the medical records) will be done by the oncologist to qualify for CXRT.

8. Patients with pre-existing Tourette's syndrome.

9. Patients with hypersensitivity to any tetracyclines.

10. Patients who are pregnant. Pregnancy will be confirmed by negative urine test. Study staff will provide the pregnancy kits to women and make sure the results are known and recorded in the follow-up notes in Clinic Station before additional study drug prescriptions are filled by the Pharmacy

11. Patients with uncontrolled cardiac disease, within the past six months history of left ventricular hypertrophy, myocardial infarction, and history of mitral valve prolapse syndrome with previous central nervous system (CNS) stimulant use.

12. Patients taking medicines that are strong CYP3A4 inhibitors or inducers (including conivaptan, indinavir, nelfinavir, ritonavir, nefazodone, and phenytoin), or strong CYP2C19 inhibitors (including citalopram and clopidogrel) .

13. Patients on vitamin K antagonist warfarin.