Non Small Cell Lung CancerPhase 1/2NCT01048983
Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)
A Phase 1/2 study testing Armodafinil, Bupropion and Minocycline in people with Non Small Cell Lung Cancer, run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Armodafinil, Bupropion and Minocycline
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Patients >= 18 years old and <= 65 years old
- 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
- Patients who speak English only (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol)
- Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol
- Patients must be willing and able to review, understand, and provide written consent before starting therapy
- 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
Who cannot join
- Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician
- Patients taking CHANTIX (smoking cessation medication)
- Patients who are enrolled in other symptom management or treatment clinical trials
- Bile duct obstruction or cholelithiasis
- History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction
- Pre-existing psychosis or bipolar disorder
Show all 22Show fewer
- Pre-existing renal impairment: The screening cut off for serum creatinine >1.5mg/dl will be done by the oncologist to qualify for CXRT.
- 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.
- Pre-existing Tourette's syndrome
- Seizure disorder
- Anorexia/bulimia in past two months
- Use of monoamine oxidase (MAO) inhibitors within 14 days
- Patients undergoing abrupt discontinuation of ethanol or sedatives (including benzodiazepines)
- Patients receiving other dosage forms of bupropion if they do not agree to undergo a washout period
- Allergy to turmeric or any of its constituents, including curcumin, to yellow food coloring, or to member of the Zingiberaceae (ginger) family
- Gastric or duodenal ulcers, or gastric hyperacidity disorders
- Hypersensitivity to any tetracyclines
- Patients to be confirmed as not pregnant (serum HCG negative). The screening for this will be done by the oncologist in qualifying for CXRT.
- Patients with a history of cardiac disease, including angina and cardiac ischemia, left ventricular hypertrophy, myocardial infarction, and mitral valve prolapse.
- Patients taking antifungals, antiretrovirals, and macrolides that are strong CYP3A4 strong inhibitors including indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, and nefazodone.
- Patients on anticoagulants (ie warfarin/heparin)
- Patients with International Normalized Ratio (INR) > 1.5.
About this study
Official title: A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer
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.
Read the detailed description
The Study Drugs:
It is not known which study drug or combination of study drugs is better at reducing side effects patients may experience during chemoradiation therapy. For this reason, researchers have chosen 4 study drugs that may help to reduce side effects. The study drugs will be tested alone and in combination with each other.
Armodafinil is designed to prevent excessive sleepiness.
Bupropion is an antidepressant with anti-inflammatory properties that may help reduce multiple symptoms.
Curcumin is the active ingredient in the spice, turmeric. It may interfere with the production of cytokines (which cause inflammation), which may reduce multiple symptoms.
Minocycline is an antibiotic. Minocycline has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 16 groups. You may be assigned to receive no study drugs, 1 study drug, or a combination of 2, 3, or all 4 of the study drugs.
During this study, you may receive 1 or more placebos. A placebo looks like the study drug(s) but has no active ingredients. There is a chance that you will be in a group that does not receive any study drugs at all. However, all patients are under standard care by their treating doctors.
Neither you nor the study staff you will see in the clinic will know if you are receiving the study drugs 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.
Study Drug Administration:
You will take the study drugs/placebos every day for 10 weeks. You will take either single or combined study drug(s) or placebos by mouth everyday as instructed by the study doctor.
You will be given pamphlets with more information about how to take the study drugs/placebos.
You will be given a daily diary to write down when you take the study drugs/placebo. You should bring your study drug/placebo blister packs/sticks to the clinic to every study visit. You should also bring your diary to every visit.
Completing the Symptom Questionnaire:
Throughout the study, you will be asked to complete the symptom questionnaire. You will be asked about symptoms from therapy you may be experiencing 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, study staff will ask you the questions and record your answers on paper or enter them into a computer. The symptom questionnaire will take up to 5 minutes to complete.
- During Weeks 1-10, you will complete the symptom questionnaire 2 times a week.
- During Weeks 11-16, you will complete the symptom questionnaire 1 time a week.
Study Visits:
Before you begin chemoradiation:
- You will complete 4 questionnaires about pain and other symptoms, your mood, and your quality of life. Completing all 4 of the questionnaires will take about 15 minutes.
- You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
- If you are a woman who is able to become pregnant, you will have a urine pregnancy test. The study staff will give you the pregnancy test kit at your scheduled visit, and will review and record the results of the test before your study prescriptions are filled by the pharmacy.
After 4 weeks of chemoradiation:
- You will complete 1 questionnaire about your quality of life. This questionnaire will take about 2-3 minutes to complete.
- You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
During the last week of chemoradiation (about Week 7):
-You will complete 3 questionnaires about your 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 you 2 times a week to check on you until week 10. This phone call should last only a few minutes. If you have experienced several side effects from chemoradiation, this phone call make take longer.
About Week 12 (at a routine clinical visit):
- You will complete 3 questionnaires about your symptoms, mood, and quality of life.
- If you were smoking at the beginning of the study, you will complete a questionnaire that asks if you stopped smoking any time during the study. This will take a few minutes.
- You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
- You will be asked to complete another questionnaire that asks about your satisfaction with the study drug(s). This will take a few minutes.
Length of Study:
You will be on study for about 16 weeks. You will take the study drug(s) for 10 weeks and complete the symptom survey until 16 weeks. You will be taken off study if you experience intolerable side effects.
This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of excessive sleepiness. Bupropion is FDA approved and commercially available for the treatment of depression. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. Curcumin is not FDA approved. At this time, curcumin is only being used in research. The different possible combinations of these drugs being used in this study is investigational.
Up to 32 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Armodafinil, Bupropion, Minocycline, Curcumin, Telephone Questionnaire
- Keywords
- Lung Cancer, NSCLC, Concurrent Chemoradiation Therapy, Side Effects, Armodafinil, Nuvigil, Bupropion, Wellbutrin, Wellbutrin SR, Zyban, Curcumin, Minocycline, Dynacin, Minocin, Minocin PAC, Myrac, Solodyn
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmodafinilDrug
Also called Nuvigil, Modafinil
Initial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks.
BupropionDrug
Also called Wellbutrin, Wellbutrin SR, Zyban
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
MinocyclineDrug
Also called Dynacin, Minocin, Minocin PAC, Myrac
Initial Dose 100 mg two times a day (200 mg) for 10 weeks.
CurcuminDrug
Initial Dose 4 gm stick pack once a day (4 gm) for 10 weeks.
Telephone QuestionnaireBehavioural
Also called Survey
Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires and Phone Calls | Other | Weeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week. Receives: Behavioral: Telephone Questionnaire |
| Curcumin Only | Active comparator | Not described Receives: Drug: Curcumin; Behavioral: Telephone Questionnaire |
| Armodafinil Only | Active comparator | Not described Receives: Drug: Armodafinil; Behavioral: Telephone Questionnaire |
| Minocycline Only | Active comparator | Not described Receives: Drug: Minocycline; Behavioral: Telephone Questionnaire |
| Bupropion Only | Active comparator | Not described Receives: Drug: Bupropion; Behavioral: Telephone Questionnaire |
| Curcumin + Armodafinil | Active comparator | Not described Receives: Drug: Armodafinil; Drug: Curcumin; Behavioral: Telephone Questionnaire |
| Curcumin + Minocycline | Active comparator | Not described Receives: Drug: Minocycline; Drug: Curcumin; Behavioral: Telephone Questionnaire |
| Curcumin + Bupropion | Active comparator | Not described Receives: Drug: Bupropion; Drug: Curcumin; Behavioral: Telephone Questionnaire |
| Armodafinil + Minocycline | Active comparator | Not described Receives: Drug: Armodafinil; Drug: Minocycline; Behavioral: Telephone Questionnaire |
| Armodafinil + Bupropion | Active comparator | Not described Receives: Drug: Armodafinil; Drug: Bupropion; Behavioral: Telephone Questionnaire |
| Minocycline + Buproprion | Active comparator | Not described Receives: Drug: Bupropion; Drug: Minocycline; Behavioral: Telephone Questionnaire |
| Curcumin + Armodafinil + Minocycline | Active comparator | Not described Receives: Drug: Armodafinil; Drug: Minocycline; Drug: Curcumin; Behavioral: Telephone Questionnaire |
| Curcumin + Armodafinil + Bupropion | Active comparator | Not described Receives: Drug: Armodafinil; Drug: Bupropion; Drug: Curcumin; Behavioral: Telephone Questionnaire |
| Curcumin + Minocycline + Bupropion | Active comparator | Not described Receives: Drug: Bupropion; Drug: Minocycline; Drug: Curcumin; Behavioral: Telephone Questionnaire |
| Armodafinil + Minocycline + Bupropion | Active comparator | Not described Receives: Drug: Armodafinil; Drug: Bupropion; Drug: Minocycline; Behavioral: Telephone Questionnaire |
| Curcumin + Armodafinil + Minocycline + Bupropion | Active comparator | Not described Receives: Drug: Armodafinil; Drug: Bupropion; Drug: Minocycline; Drug: Curcumin; Behavioral: Telephone Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined AUC for Selected Symptoms
Measured: 10-weeks (+/- 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
Why it stopped: No accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Zhongxing Liao, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048983
- Sponsor's protocol ID
- 2008-0345
- Other IDs
- R01 026582-26, NCI-2012-01256
- Status last verified
- Mar 2015
- First submitted
- 12 Jan 2010
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Reducing the Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01048983
- Acronym / sponsor ID
- 2008-0345
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Lung Cancer, NSCLC, Concurrent Chemoradiation Therapy, Side Effects, Armodafinil, Nuvigil, Bupropion, Wellbutrin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Study Drugs:
It is not known which study drug or combination of study drugs is better at reducing side effects patients may experience during chemoradiation therapy. For this reason, researchers have chosen 4 study drugs that may help to reduce side effects. The study drugs will be tested alone and in combination with each other.
Armodafinil is designed to prevent excessive sleepiness.
Bupropion is an antidepressant with anti-inflammatory properties that may help reduce multiple symptoms.
Curcumin is the active ingredient in the spice, turmeric. It may interfere with the production of cytokines (which cause inflammation), which may reduce multiple symptoms.
Minocycline is an antibiotic. Minocycline has been shown to interrupt cytokine production, which may help to reduce multiple symptoms.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the roll of dice) to join 1 of 16 groups. You may be assigned to receive no study drugs, 1 study drug, or a combination of 2, 3, or all 4 of the study drugs.
During this study, you may receive 1 or more placebos. A placebo looks like the study drug(s) but has no active ingredients. There is a chance that you will be in a group that does not receive any study drugs at all. However, all patients are under standard care by their treating doctors.
Neither you nor the study staff you will see in the clinic will know if you are receiving the study drugs 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.
Study Drug Administration:
You will take the study drugs/placebos every day for 10 weeks. You will take either single or combined study drug(s) or placebos by mouth everyday as instructed by the study doctor.
You will be given pamphlets with more information about how to take the study drugs/placebos.
You will be given a daily diary to write down when you take the study drugs/placebo. You should bring your study drug/placebo blister packs/sticks to the clinic to every study visit. You should also bring your diary to every visit.
Completing the Symptom Questionnaire:
Throughout the study, you will be asked to complete the symptom questionnaire. You will be asked about symptoms from therapy you may be experiencing 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, study staff will ask you the questions and record your answers on paper or enter them into a computer. The symptom questionnaire will take up to 5 minutes to complete.
- During Weeks 1-10, you will complete the symptom questionnaire 2 times a week.
- During Weeks 11-16, you will complete the symptom questionnaire 1 time a week.
Study Visits:
Before you begin chemoradiation:
- You will complete 4 questionnaires about pain and other symptoms, your mood, and your quality of life. Completing all 4 of the questionnaires will take about 15 minutes.
- You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
- If you are a woman who is able to become pregnant, you will have a urine pregnancy test. The study staff will give you the pregnancy test kit at your scheduled visit, and will review and record the results of the test before your study prescriptions are filled by the pharmacy.
After 4 weeks of chemoradiation:
- You will complete 1 questionnaire about your quality of life. This questionnaire will take about 2-3 minutes to complete.
- You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
During the last week of chemoradiation (about Week 7):
-You will complete 3 questionnaires about your 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 you 2 times a week to check on you until week 10. This phone call should last only a few minutes. If you have experienced several side effects from chemoradiation, this phone call make take longer.
About Week 12 (at a routine clinical visit):
- You will complete 3 questionnaires about your symptoms, mood, and quality of life.
- If you were smoking at the beginning of the study, you will complete a questionnaire that asks if you stopped smoking any time during the study. This will take a few minutes.
- You will have a blood coagulation test, called a PT-INR, to make sure your blood clots normally.
- You will be asked to complete another questionnaire that asks about your satisfaction with the study drug(s). This will take a few minutes.
Length of Study:
You will be on study for about 16 weeks. You will take the study drug(s) for 10 weeks and complete the symptom survey until 16 weeks. You will be taken off study if you experience intolerable side effects.
This is an investigational study. Armodafinil is FDA approved and commercially available for the treatment of excessive sleepiness. Bupropion is FDA approved and commercially available for the treatment of depression. Minocycline is FDA approved and commercially available for the treatment of bacterial infection. Curcumin is not FDA approved. At this time, curcumin is only being used in research. The different possible combinations of these drugs being used in this study is investigational.
Up to 32 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Questionnaires and Phone Calls | Other | Behavioral: Telephone QuestionnaireWeeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week. |
| Curcumin Only | Active comparator | Drug: Curcumin, Behavioral: Telephone Questionnaire |
| Armodafinil Only | Active comparator | Drug: Armodafinil, Behavioral: Telephone Questionnaire |
| Minocycline Only | Active comparator | Drug: Minocycline, Behavioral: Telephone Questionnaire |
| Bupropion Only | Active comparator | Drug: Bupropion, Behavioral: Telephone Questionnaire |
| Curcumin + Armodafinil | Active comparator | Drug: Armodafinil, Drug: Curcumin, Behavioral: Telephone Questionnaire |
| Curcumin + Minocycline | Active comparator | Drug: Minocycline, Drug: Curcumin, Behavioral: Telephone Questionnaire |
| Curcumin + Bupropion | Active comparator | Drug: Bupropion, Drug: Curcumin, Behavioral: Telephone Questionnaire |
| Armodafinil + Minocycline | Active comparator | Drug: Armodafinil, Drug: Minocycline, Behavioral: Telephone Questionnaire |
| Armodafinil + Bupropion | Active comparator | Drug: Armodafinil, Drug: Bupropion, Behavioral: Telephone Questionnaire |
| Minocycline + Buproprion | Active comparator | Drug: Bupropion, Drug: Minocycline, Behavioral: Telephone Questionnaire |
| Curcumin + Armodafinil + Minocycline | Active comparator | Drug: Armodafinil, Drug: Minocycline, Drug: Curcumin, Behavioral: Telephone Questionnaire |
| Curcumin + Armodafinil + Bupropion | Active comparator | Drug: Armodafinil, Drug: Bupropion, Drug: Curcumin, Behavioral: Telephone Questionnaire |
| Curcumin + Minocycline + Bupropion | Active comparator | Drug: Bupropion, Drug: Minocycline, Drug: Curcumin, Behavioral: Telephone Questionnaire |
| Armodafinil + Minocycline + Bupropion | Active comparator | Drug: Armodafinil, Drug: Bupropion, Drug: Minocycline, Behavioral: Telephone Questionnaire |
| Curcumin + Armodafinil + Minocycline + Bupropion | Active comparator | Drug: Armodafinil, Drug: Bupropion, Drug: Minocycline, Drug: Curcumin, Behavioral: Telephone Questionnaire |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
- Patients >= 18 years old and <= 65 years old
- 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
- Patients who speak English only (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol)
- Patients must agree to discontinue any current herbal supplement use, and refrain from taking any herbal supplement while on protocol
Key exclusion criteria (22 listed)
- Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician
- Patients taking CHANTIX (smoking cessation medication)
- Patients who are enrolled in other symptom management or treatment clinical trials
- Bile duct obstruction or cholelithiasis
- History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArmodafinilAlso: Nuvigil, ModafinilInitial Dose 150 mg once a day (50 mg and 100 mg oral tablets) for 10 weeks. | Drug | Armodafinil + Bupropion, Armodafinil + Minocycline, Armodafinil + Minocycline + Bupropion, Armodafinil Only, Curcumin + Armodafinil, Curcumin + Armodafinil + Bupropion, Curcumin + Armodafinil + Minocycline, Curcumin + Armodafinil + Minocycline + Bupropion |
| BupropionAlso: Wellbutrin, Wellbutrin SR, ZybanInitial Dose 100 mg two times a day (200 mg) for 10 weeks. | Drug | Armodafinil + Bupropion, Armodafinil + Minocycline + Bupropion, Bupropion Only, Curcumin + Armodafinil + Bupropion, Curcumin + Armodafinil + Minocycline + Bupropion, Curcumin + Bupropion, Curcumin + Minocycline + Bupropion, Minocycline + Buproprion |
| MinocyclineAlso: Dynacin, Minocin, Minocin PAC, MyracInitial Dose 100 mg two times a day (200 mg) for 10 weeks. | Drug | Armodafinil + Minocycline, Armodafinil + Minocycline + Bupropion, Curcumin + Armodafinil + Minocycline, Curcumin + Armodafinil + Minocycline + Bupropion, Curcumin + Minocycline, Curcumin + Minocycline + Bupropion, Minocycline + Buproprion, Minocycline Only |
| CurcuminInitial Dose 4 gm stick pack once a day (4 gm) for 10 weeks. | Drug | Curcumin + Armodafinil, Curcumin + Armodafinil + Bupropion, Curcumin + Armodafinil + Minocycline, Curcumin + Armodafinil + Minocycline + Bupropion, Curcumin + Bupropion, Curcumin + Minocycline, Curcumin + Minocycline + Bupropion, Curcumin Only |
| Telephone QuestionnaireAlso: SurveyWeeks 1-10, 2 questionnaire calls/week; and Weeks 11-16, 1 call/week. | Behavioural | Armodafinil + Bupropion, Armodafinil + Minocycline, Armodafinil + Minocycline + Bupropion, Armodafinil Only, Bupropion Only, Curcumin + Armodafinil, Curcumin + Armodafinil + Bupropion, Curcumin + Armodafinil + Minocycline, Curcumin + Armodafinil + Minocycline + Bupropion, Curcumin + Bupropion, Curcumin + Minocycline, Curcumin + Minocycline + Bupropion, Curcumin Only, Minocycline + Buproprion, Minocycline Only, Questionnaires and Phone Calls |
Primary outcome
Combined AUC for Selected Symptoms
Time frame: 10-weeks (+/- 4 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongxing Liao, MD study chair
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Armodafinil, Bupropion and Minocycline in people with Non Small Cell Lung Cancer, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined AUC for Selected Symptoms (time frame: 10-weeks (+/- 4 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.