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

NCT01636934 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2012-0347NCI-2018-01837R01CA026582
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

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

Outcome Measures

Primary Outcomes (1)

• AUC Value Symptom Severity Differences

  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. Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference.

  up to 12 weeks

Secondary Outcomes (1)

• Number of Participants With Treatment-Induced Inflammatory Response

  up to 12 weeks

Study Arms (2)

Minocycline

EXPERIMENTAL

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; Behavioral: Questionnaires

Placebo

PLACEBO COMPARATOR

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; Behavioral: Questionnaires

Interventions

Minocycline DRUG

100 mg by mouth two times a day (200 mg/day) every day for 7 weeks, starting on the first week of chemoradiation therapy.

Also known as: Dynacin, Minocin, Minocin PAC, Myrac, Solodyn

Minocycline

Placebo OTHER

1 capsule by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy.

Also known as: sugar pill

Placebo

Questionnaires BEHAVIORAL

Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.

Also known as: Surveys

Minocycline; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a pathologically proven diagnosis of NSCLC and consented to receive CXRT at MD Anderson
• Patients \> or = 18 years old
• 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
• Patients who speak English or Spanish (due to MDASI language options, we are only accruing English-speaking or Spanish-speaking patients to the protocol)
• Patients willing and able to review, understand, and provide written consent before starting therapy
• Patients with normal renal function according to MD Anderson testing standards and no prior renal disease \[screening cut off for serum creatinine \< 1.5 times ULN\]
• 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

You may not qualify if:

• Patients with a history of clinically significant cutaneous drug reaction to minocycline, as documented in the patient medical records
• Patients who are enrolled in other symptom management or symptom clinical trials
• Patients who currently have bile duct obstruction or cholelithiasis
• Patients with hypersensitivity to any tetracyclines
• Patients who are pregnant; pregnancy will be confirmed by negative urine test
• Patients on vitamin K antagonist warfarin

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; cyclopia sequence

Interventions

Minocycline; Sugars; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbohydrates; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Zhongxing Liao, MD/ Professor, Radiation Oncology Department
• Organization: UT MD Anderson Cancer Center

zliao@mdanderson.org

(713) 563-2300

Study Officials

• Zhongxing Liao, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2012
• First Posted: July 10, 2012
• Study Start: July 1, 2012
• Primary Completion: September 23, 2019
• Study Completion: September 23, 2019
• Last Updated: July 17, 2020
• Results First Posted: July 17, 2020

Record last verified: 2020-07

Locations

US (1)