Minocycline Study in Non Small Cell Lung Cancer (NSCLC) Patients for Chemoradiation Therapy
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Minocycline; Placebo; Questionnaires
Intervention description: 100 mg by mouth two times a day (200 mg/day) every day for 7 weeks, starting on the first week of chemoradiation therapy.; 1 capsule 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.
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer; Non Small Cell Lung Cancer; NSCLC; Symptom Burden; Chemoradiation; CXRT; Minocycline; Dynacin; Minocin; Minocin PAC; Myrac; Solodyn; Placebo; Sugar Pill; Questionnaires; Surveys

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.
    

Eligibility 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