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

This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01636934
First received: July 5, 2012
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Lung Cancer
 Drug: Minocycline
Other: Placebo
Behavioral: Questionnaires
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • AUC Value Symptom Severity Differences [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Effectiveness of Minocycline in Reducing Treatment-Induced Inflammatory Response [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 with normal hepatic function according to MD Anderson testing standards and no prior liver disease [screening results for total bilirubin must be < 1.5 times the upper limit of normal; screening results for the following must be < 2 times the upper limit of normal for patients to be eligible: alkaline phosphatase (ALP) and alanine aminotransferase (ALT); screening results for aspartate aminotransferase (AST) must be < 2 times the upper limit of normal if available]

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636934

Contacts
Contact: Zhongxing Liao, MD 713-745-3470

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

Additional Information:
UT MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01636934     History of Changes
Other Study ID Numbers: 2012-0347
Study First Received: July 5, 2012
Last Updated: March 1, 2013
Health Authority: United States: Federal Government

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013