Minocycline Study in Non Small Cell Lung Cancer (NSCLC) Patients for Chemoradiation Therapy
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: Minocycline (Drug); Placebo (Other); Questionnaires (Behavioral)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Zhongxing Liao, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to learn if minocycline can reduce the side
effects reported by patients with NSCLC who are receiving chemoradiation therapy. In this
study, minocycline will be compared to a placebo.
Minocycline is an antibiotic that may help to reduce side effects of chemoradiation therapy.
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.
Clinical Details
Official title: A Randomized, Placebo Controlled-Double Blind Study of Minocycline 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, Investigator), Primary Purpose: Treatment
Primary outcome: AUC Value Symptom Severity Differences
Secondary outcome: Effectiveness of Minocycline in Reducing Treatment-Induced Inflammatory Response
Detailed description:
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 groups. Group 1 will take minocycline. Group 2 will take a placebo.
Neither you nor the study staff will know if you are receiving the study drug or the
placebo. However, if needed for your safety, the study staff will be able to find out what
you are receiving.
Study Drug Administration:
You will take the study drug/placebo by mouth, every day during chemoradiation therapy.
You may take the study drug/placebo with a full glass (8 ounces) of water. You may take it
with or without food, but if it causes an upset stomach, you should take it with food.
If you have trouble swallowing the dose of study drug/placebo, you can open the capsule
right before you take it. You should not lie down for at least 30 minutes after taking the
study drug/placebo to reduce the risk of side effects.
You must bring the study drug/placebo container (along with any remaining drug) to every
study visit.
Study Visits:
Before you start your chemoradiation treatment:
- You will fill out 4 questionnaires about pain and other symptoms, your tobacco history,
your health status, and your quality of life. It should take about 15 minutes to
complete all of the questionnaires.
- Blood (about 1 tablespoon) will be drawn for biomarker testing. Biomarkers are found in
the blood/tissue and may be related to your reaction to the study drug.
During chemoradiation treatment:
- During Week 1 of chemoradiation, blood (about 1 tablespoon) will be drawn for biomarker
testing.
- You will complete the symptom questionnaire in the clinic or by telephone 1 time each
week. The symptom questionnaire should take about 5 minutes to complete each time.
- Each week you will be asked about any symptoms you may be having and how they may be
affecting your daily activities.
At about Week 4 of chemoradiation:
- You will complete 3 questionnaires about pain and other symptoms, your health status, and
your quality of life. It should take about 10 minutes to complete all of the questionnaires.
During the last week of chemoradiation:
- You will complete 4 questionnaires about pain and other symptoms, your health status,
your quality of life, and your satisfaction with the study drug/placebo. It should take
about 15 minutes to complete all of the questionnaires.
- Blood (about 1 tablespoon) will be drawn for biomarker testing.
After the last week of chemoradiation:
- The study staff will call you 1 time each week to check on you and to complete the pain
and symptoms questionnaire at a time that is convenient for you. This phone call
should last about 10 minutes. If you have had several side effects from the
chemoradiation therapy, this phone call may take longer.
- At about Week 12, blood (about 1 tablespoon) will be drawn for biomarker testing.
End of Study Visit:
Your last study visit will be the same day that you have your last clinic visit with the
chemoradiation doctor (around Weeks 12-13). At this visit, you will complete the pain and
other symptoms questionnaire, the health status questionnaire, and the smoking
questionnaires. It should take about 10 minutes to complete all questionnaires.
Length of Study:
You will be on study for up to 13 weeks. You will take the study drug/placebo every day
during chemoradiation treatment, and continue to complete the questionnaires until 12-13
weeks. You will be taken off study early if you have intolerable side effects or the study
doctor thinks it is in your best interest.
This is an investigational study. Minocycline is FDA approved and commercially available
for the treatment of bacterial infection. Using minocycline to treat side effects of
chemoradiation treatment in patients with NSCLC is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Eligibility
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 receive
CXRT at MD Anderson
2. Patients > or = 18 years old
3. Patients who will receive CXRT with platinum/taxane-based chemotherapy and with a
total radiation dose of >or = 50 Gy, per treating physician's assessment
4. Patients who speak English or Spanish (due to MDASI language options, we are only
accruing English-speaking or Spanish-speaking patients to the protocol)
5. Patients willing and able to review, understand, and provide written consent before
starting therapy
6. Patients with normal renal function according to MD Anderson testing standards and no
prior renal disease [screening cut off for serum creatinine < 1. 5 times ULN]
7. Patients must have the following screening results for hepatic function according to
MD Anderson testing standards: total bilirubin < 1. 5 times the upper limit of normal;
alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate
aminotransferase (AST - if available) must be < 2 times the upper limit of normal
Exclusion Criteria:
1. Patients with a history of clinically significant cutaneous drug reaction to
minocycline, as documented in the patient medical records
2. Patients who are enrolled in other symptom management or symptom clinical trials
3. Patients who currently have bile duct obstruction or cholelithiasis
4. Patients with hypersensitivity to any tetracyclines
5. Patients who are pregnant; pregnancy will be confirmed by negative urine test
6. Patients on vitamin K antagonist warfarin
Locations and Contacts
University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
University of Texas MD Anderson Cancer Center Website
Starting date: July 2012
Last updated: August 20, 2015
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