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

• Status: Completed
• Trial end date: 2019-09-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Minocycline

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