Reducing Symptom Burden - 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• Status: Withdrawn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 compare armodafinil, bupropion, curcumin, 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: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Patients with a pathologically proven diagnosis of unresectable Non-small-cell lung carcinoma (NSCLC) and consented to concurrent chemoradiation therapy in MD Anderson Cancer Center (MDACC).

2. Patients >= 18 years old and <= 65 years old

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

4. Patients who speak English only (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 before starting therapy

7. Patients already taking any of this trial's symptom treatment medications (including modafinil) must be willing to stop taking the medication/s for a washout period of 30 days before they are randomized to a symptom treatment arm and begin the symptom 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 or treatment clinical trials

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

7. Pre-existing renal impairment: The screening cut off for serum creatinine >1.5mg/dl will be done by the oncologist to qualify for CXRT.

8. Pre-existing hepatic impairment: The screening for total bilirubin >25.7 µmol/L (1.5 mg/dL) will be done by the oncologist to qualify for chemoradiation treatment (CXRT). The screening for 2 times the upper limit of normal Hepatotoxicity (Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT) will be done by the oncologist to qualify for CXRT.

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 receiving other dosage forms of bupropion if they do not agree to undergo a washout period

15. Allergy to turmeric or any of its constituents, including curcumin, to yellow food coloring, or to member of the Zingiberaceae (ginger) family

16. Gastric or duodenal ulcers, or gastric hyperacidity disorders

17. Hypersensitivity to any tetracyclines

18. Patients to be confirmed as not pregnant (serum HCG negative). The screening for this will be done by the oncologist in qualifying for CXRT.

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

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

21. Patients on anticoagulants (ie warfarin/heparin)

22. Patients with International Normalized Ratio (INR) > 1.5.