A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
18 Years
N/A
Both
Esophageal Cancer
Trial Information
A Randomized Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer
Study Groups:
If you are eligible to take part in this study, you will be randomly assigned (as in the
roll of dice) to join 1 of 4 groups. You will have an equal chance of being in any group.
- 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 2 placebos.
Neither you nor the study staff you will see in the clinic will know if you are receiving
the study drug(s) and/or the placebo(s). However, if needed for your safety, the study
staff will be able to find out which study drug you are receiving.
If needed, you will be given standard drugs to help decrease the risk of side effects. You
may ask the study staff for information about how the drugs are given and their risks.
Study Drug/Placebo Administration:
You will take the study drug/placebo 2 times a day for 6 weeks. You should take the capsules
with a full glass of water. If you get an upset stomach, take them with food.
You will be given pamphlets with more information about how to take the study capsules.
You should bring your study capsules to every study visit.
Completing the Symptom Questionnaire:
Throughout the study, you will be asked to complete a questionnaire about your symptoms.
This questionnaire will ask about symptoms from therapy you may be having and how they may
be interfering with your daily activities. The study staff will either meet you during your
regular clinic visit or call you at your home at a time that is convenient for you. In the
clinic, you will complete the questionnaire by paper and pen, or by entering your answers
into an electronic tablet computer. On the phone, a study staff member will ask you the
questions and record your answers. You will complete the symptom questionnaire before you
begin chemoradiation and then 1 time a week during Weeks 1-10 of the study. The symptom
questionnaire will take up to 5 minutes to complete.
Study Visits:
Before you begin chemoradiation:
- You will complete questionnaires about pain and other symptoms, your mood, and your
quality of life. Completing all 5 questionnaires will take about 15 minutes.
- If you can become pregnant and you did not have a pregnancy test during screening, you
will have a urine pregnancy test. The study staff will give you the urine pregnancy
test kit at your scheduled visit, and will review the results before you pick up the
study capsules from the pharmacy.
About Week 3 or 4, you will be asked to complete a questionnaire that asks you about your
satisfaction with the study capsules. This will take a few minutes.
During the last week of chemoradiation (about Week 5 or 6):
- You will complete 3 questionnaires about your symptoms, mood, and quality of life.
These questionnaires will take about 10 minutes total to complete.
- You will also be asked to complete a questionnaire that asks about your satisfaction
with the study capsules. This will take a few minutes.
After about Week 5 or 6, the study staff will call you 1 time a week to check on you until
Week 10 or 11. This phone call should last only a few minutes. If you have had several side
effects from chemoradiation, this phone call may take longer.
About Week 10 or 11 (or at the first routine clinical follow-up visit):
- You will complete the 3 questionnaires about your symptoms, mood, and quality of life.
- You will also be asked to complete another questionnaire that asks about your
satisfaction with the study capsules.
Length of Study:
You will be on study for about 10-11 weeks. You will take the study drug(s) for 6 weeks and
complete the symptom survey until Week 10 or 11. You will be taken off study early if you
have intolerable side effects.
This is an investigational study. Armodafinil is FDA approved and commercially available
for the treatment of 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 80 patients will take part in this study. All will be enrolled at MD Anderson.
Inclusion Criteria:
1. Patients with a pathologically proven diagnosis of esophageal cancer
2. Patients > or = 18 years old
3. Patients who will receive chemotherapy and radiation therapy
4. Patients who speak English or Spanish
5. Patients must be willing and able to review, understand, and provide written consent
before starting therapy
6. Patients must agree to discontinue St John's Wort herbal supplement use, and refrain
from taking it while on protocol
7. Women of childbearing potential (women who are not postmenopausal for at least 1 year
and are not surgically sterile) must have a negative urine pregnancy test
8. Sexually active males and females must agree to use effective birth control or to be
abstinent for the duration of the study period
9. Women currently taking birth control pills or planning to start birth control pills
must agree to an additional method of birth control (either abstinence or a barrier
method) while on the study medication and for 1 additional month after study
completion.
Exclusion Criteria:
1. Patients who are enrolled in other symptom management clinical trials
2. Patients currently taking methylphenidate and/or dextroamphetamine
3. Patients with a history of clinically significant cutaneous drug reaction, or a
history of clinically significant hypersensitivity reaction, as documented in the
patient medical records
4. Patients with pre-existing psychosis or bipolar disorder
5. Patients with pre-existing renal impairment: The screening cut off for serum
creatinine >1.5 times the upper limit of normal, within the past 30 days, will be
done by the oncologist to qualify for CXRT.
6. 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.
7. Patients with pre-existing Tourette's syndrome
8. Patients with hypersensitivity to any tetracyclines
9. Patients with uncontrolled cardiac disease, including angina and cardiac ischemia,
left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
10. Patients taking medicines that are strong CYP3A4 inhibitors or inducers (including
conivaptan, indinavir, nelfinavir, ritonavir, nefazodone, and phenetoin), or strong
CYP2C19 inhibitors (including citalopram and clopidogrel).
11. Patients on vitamin K antagonist warfarin
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Mean Symptom Increase During Chemoradiation Therapy
Outcome Description:
Mean symptom score at both time points defined as the mean of the patients MDASI scores for the symptoms of fatigue, drowsiness, sleep disturbance, pain and lack of appetite.
Outcome Time Frame:
6 weeks
Safety Issue:
Yes
Principal Investigator
Steven H. Lin, MD, PHD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
2012-0117
NCT ID:
NCT01746043
Start Date:
February 2013
Completion Date:
Related Keywords:
- Esophageal Cancer
- Esophageal cancer
- Chemotherapy
- Radiation therapy
- XRT
- Chemoradiation
- CXRT
- Symptom Burden
- Armodafinil
- Nuvigil
- Minocycline
- Dynacin
- Minocin
- Minocin PAC
- Myrac
- Solodyn
- Placebo
- Sugar pill
- Questionnaires
- Surveys
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
