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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01636934
First received: July 5, 2012
Last updated: May 30, 2014
Last verified: May 2014
  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:


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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Zhongxing Liao, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01636934     History of Changes
Other Study ID Numbers: 2012-0347, NCI-2012-01249, R01CA026582
Study First Received: July 5, 2012
Last Updated: May 30, 2014
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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014