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Minocycline Study in Non Small Cell Lung Cancer (NSCLC) Patients for Chemoradiation Therapy

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ClinicalTrials.gov Identifier: NCT01636934
Recruitment Status : Active, not recruiting
First Posted : July 10, 2012
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Minocycline Other: Placebo Behavioral: Questionnaires Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2012
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Minocycline
Two-arm, placebo-controlled pilot study to obtain preliminary estimates of treatment effects of minocycline in patients with non small cell lung cancer (NSCLC) being consented for concurrent chemoradiation (CXRT). Minocycline 100 mg capsules taken by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy. Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
Drug: Minocycline
100 mg by mouth two times a day (200 mg/day) every day for 7 weeks, starting on the first week of chemoradiation therapy.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn
Behavioral: Questionnaires
Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
Other Name: Surveys
Placebo Comparator: Placebo
Two-arm, placebo-controlled pilot study to obtain preliminary estimates of treatment effects of minocycline in patients with non small cell lung cancer (NSCLC) being consented for concurrent chemoradiation (CXRT). Placebo capsules taken by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy. Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
Other: Placebo
1 capsule by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy.
Other Name: sugar pill
Behavioral: Questionnaires
Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
Other Name: Surveys



Primary Outcome Measures :
  1. AUC Value Symptom Severity Differences [ Time Frame: 12 weeks ]
    Primary outcome variable for this trial will be the mean difference between AUC values recorded for patients assigned to the treatment and control arms. AUC values calculated for the five M.D. Anderson Symptom Inventory (MDASI) items corresponding to fatigue, pain, disturbed sleep, lack of appetite, and sore throat. AUC is sum of the area of the trapezoids that can be fitted during the 12 week period and is measured in units of mean MDASI score in days.


Secondary Outcome Measures :
  1. Effectiveness of Minocycline in Reducing Treatment-Induced Inflammatory Response [ Time Frame: 12 weeks ]
    Analyses will include linear regression analyses of AUC values on measured CRP, IL-6, TNF-a, sTNF-R1, sTNF-R2, and IDO values, as well as longitudinal analyses of the relationship between individual symptom scores as measured by M.D. Anderson Symptom Inventory (MDASI) and CRP, IL-6, TNF-a, sTNF-R1, sTNF-R2, and IDO variables. Using linear regression analyses, effects of minocycline treatment on each of the serum markers examined.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636934


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Zhongxing Liao, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01636934     History of Changes
Other Study ID Numbers: 2012-0347
NCI-2012-01249 ( Registry Identifier: NCI CTRP )
R01CA026582 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Non Small Cell Lung Cancer
NSCLC
Symptom Burden
Chemoradiation
CXRT
Minocycline
Dynacin
Minocin
Minocin PAC
Myrac
Solodyn
Placebo
Sugar Pill
Questionnaires
Surveys

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents