CompletedPhase 2NCT01636934
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMinocycline and Placebo

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 17, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Drug: Minocycline; Other: Placebo; Behavioral: Questionnaires
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 17, 2020. Always confirm current availability with the study team.

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