Symptom Burden in Head and Neck Cancer

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to compare armodafinil, bupropion, and minocycline when given alone or in combination. Researchers want to learn about the safety and level of effectiveness of these drugs in controlling symptoms, such as the side effects of chemoradiation, when given to patients with head and neck cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Patients with a pathologically proven diagnosis of epithelial carcinoma of the oropharynx, nasopharynx, hypopharynx, larynx, or oral cavity being treated at MDACC.

2. Patients >/= 18 years old and

3. Patients with the above cancers scheduled to receive definitive concurrent chemoradiation over 6 - 7 weeks.

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

5. Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol.

6. Patients must be willing and able to review, understand, and provide written consent.

7. Women of childbearing potential (women who are not postmenopausal for at least one year and are not surgically sterile) must have negative urine pregnancy test..

8. Sexually active males and females must agree to use birth control or abstinence for the duration of the trial.

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 taking CHANTIX (smoking cessation medication)

3. Patients who are enrolled in other symptom management trial or receiving active therapy as part of a treatment clinical trial.

4. Bile duct obstruction or cholelithiasis

5. History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction

6. Pre-existing psychosis or bipolar disorder. Patients with major depressive disorder or severe depression (a score of 13 or greater on the BDI Fast Screen (BDI-FS) will be excluded. If this is the case, we will notify their treating physician for appropriate management or referral.

7. Pre-existing renal impairment: The screening cut off for serum creatinine > the upper limit of normal, will be done by the oncologist to qualify for chemoradiation.

8. Pre-existing hepatic impairment: The screening for total bilirubin > 1.5 times the upper limit of normal will be done by the oncologist to qualify for chemoradiation. The screening for >2 times the upper limit of normal hepatotoxicity: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT) will be done by the oncologist to qualify for chemoradiation.The screening results for Aspartate aminotransferase (AST) must be < 2 times the upper limit of normal if available in the medical records.

9. Pre-existing Tourette's syndrome

10. Seizure disorder

11. Anorexia/bulimia in past two months

12. Use of monoamine oxidase (MAO inhibitors) within 14 days

13. Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)

14. Patients currently taking any of the study drugs

15. Hypersensitivity to any tetracyclines

16. Patients on anticoagulants (ie warfarin/heparin)

17. Patients with INR > 1.5.

18. Patients being treated with concurrent cetuximab chemotherapy with radiation therapy.

19. Patients currently receiving any tetracycline family antibiotic or within the previous past 14 days before chemoradiation.

20. Previous radiation therapy for a cancer in the head and neck region.

21. Patients with a history of cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.

22. Patients taking antifungals, antiretrovirals, and macrolides that are strong CYP3A4 strong inhibitors including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, and nefazodone.