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

Condition(s) targeted: Lung Cancer

Intervention: Armodafinil (Drug); Placebo (Other); Minocycline (Drug); Questionnaires (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Zhongxing Liao, MD, Principal Investigator, Affiliation: UT MD Anderson Cancer Center

Overall contact:
Zhongxing Liao, MD, Phone: 713-745-3470

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.

Official title: A Pilot Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Primary outcome: 10-week AUC for 5 targeted symptoms

Detailed description: The Study Drugs:

Armodafinil is designed to prevent excessive sleepiness.

Minocycline is an antibiotic. Minocycline has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Study Groups:

If patient agrees to take part in this study, they will be randomly assigned (as in the roll of dice) to join 1 of 4 groups.

- Group 1 will take armodafinil and a placebo.

- Group 2 will take minocycline and a placebo.

- Group 3 will take armodafinil and minocycline.

- Group 4 will take placebos alone.

Neither patient nor the study staff patient will see in the clinic will know if they are receiving the study drug(s) and/or the placebo(s). However, if needed for patient's safety, the study staff will be able to find out which study drug they are receiving.

If needed, during this study, patient may receive standard care by their treating doctors.

Study Drug Administration:

Patient will take the study drug(s)/placebos every day for 10 weeks. Patient should take the drug(s)/placebo(s) with a full glass of water. If patient gets an upset stomach, take them with food.

Patient will be given pamphlets with more information about how to take the study drugs/placebos.

Patient should bring their study drug/placebo capsules to the clinic every study visit.

Completing the Symptom Questionnaire:

Throughout the study, patient will be asked to complete the symptom questionnaire. Patient will be asked about symptoms from therapy they may be experiencing and how they may be interfering with their daily activities. The study staff will either meet patient during their regular clinic visit or call patient at their home at a time that is convenient for the patient. In the clinic, patient will complete the questionnaire by paper and pen, or by entering their answers into an electronic tablet computer. On the phone, study staff will ask patient the questions and record their answers on paper or enter them into a computer. Patient will complete the symptom questionnaire before they begin chemoradiation and then 1 time a week during Weeks 1-16 of the study. The symptom questionnaire will take up to 5 minutes to complete.

Study Visits:

Before patient begins chemoradiation:

- Patient will complete 4 questionnaires about pain and other symptoms, their mood, and

their quality of life. Completing all 4 of the questionnaires will take about 15 minutes.

- If patient is able to become pregnant, they will have a urine pregnancy test. The study

staff will give patient the pregnancy test kit at their scheduled visit, and will review and record the results of the test before patient can pick up the study drugs from the pharmacy.

During the last week of chemoradiation (about Week 7):

- Patient will complete 3 questionnaires about their symptoms, mood, and quality of life.

These questionnaires will take about 10 minutes total to complete.

After about Week 7, the study staff will call patient 1 time a week to check on patient until Week 10. This phone call should last only a few minutes. If patient has had several side effects from chemoradiation, this phone call may take longer.

About Week 12 (at a routine clinical visit):

- Patient will complete the 3 questionnaires about their symptoms, mood, and quality of

life.

- If patient was smoking at the beginning of the study, they will complete a

questionnaire that asks if they stopped smoking any time during the study. This will take a few minutes to complete.

- Patient will be asked to complete another questionnaire that asks about their

satisfaction with the study drug(s). This will take a few minutes.

Length of Study:

Patient will be on study for about 16 weeks. Patient will take the study drug(s) for 10 weeks and complete the symptom survey until Week 16. Patient will be taken off study early if they have intolerable side effects.

This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of excessive sleepiness. Minocycline is FDA approved and commercially available for the treatment of bacterial infections. The use of these drugs to help reduce chemoradiation symptoms is investigational.

Up to 12 patients will take part in this study. All will be enrolled at MD Anderson.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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, or currently taking SSRIs.

6. Patients with pre-existing renal impairment: The screening cut off for serum creatinine >1. 5mg/dL, within the past 30 days, will be done by the oncologist to qualify for CXRT.

7. Patients with 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 CXRT. The screening for > 2 times the upper limit of normal hepatotoxicity, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 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, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.

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

Zhongxing Liao, MD, Phone: 713-745-3470

UT MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting

UT MD Anderson Website

Starting date: July 2011
Last updated: September 21, 2012