A Study for Reducing Symptom Burden Produced by Chemoradiation Treatment for Non Small Cell Lung Cancer by Minocycline and Armodafinil

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01317550
First received: March 16, 2011
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

The goal of this clinical research study is to compare armodafinil and minocycline when given alone or in combination to learn which is better for controlling symptoms, such as the side effects of chemoradiation, when given to treat lung cancer.


Condition Intervention
Lung Cancer
Drug: Armodafinil
Other: Placebo
Drug: Minocycline
Behavioral: Questionnaires

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Minocycline and Armodafinil 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:
  • 10-week AUC for 5 targeted symptoms [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Estimates of treatment effects and the variability of these estimates using a 10-week (+/- 2 days) area under the curve (AUC) for 5 targeted symptoms: fatigue, pain, disturbed sleep, lack of appetite, and drowsiness, either as a combination or individually. Baseline assessments within 2 days of start of CXRT, while symptom intervention agents start day of CXRT or within 2 days of the start of CXRT.


Estimated Enrollment: 12
Study Start Date: July 2011
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Armodafinil + Placebo
Armodafinil orally 150 mg/day + Placebo capsules for 10 weeks
Drug: Armodafinil
150 mg by mouth once a day for a 10 week cycle.
Other Name: Nuvigil
Other: Placebo
Capsules taken by mouth once a day for a 10 week cycle.
Other Name: Sugar Pill
Behavioral: Questionnaires
Completion of symptom questionnaire before chemoradiation, then once a week during Weeks 1-16, takes up to 5 minutes to complete.
Other Name: Surveys
Experimental: Minocycline + Placebo
Minocycline orally 100 mg twice/day + Placebo capsules for 10 weeks
Other: Placebo
Capsules taken by mouth once a day for a 10 week cycle.
Other Name: Sugar Pill
Drug: Minocycline
100 mg by mouth twice a day for a 10 week cycle.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn
Behavioral: Questionnaires
Completion of symptom questionnaire before chemoradiation, then once a week during Weeks 1-16, takes up to 5 minutes to complete.
Other Name: Surveys
Experimental: Armodafinil + Minocycline
Armodafinil orally 150 mg/day for 10 weeks + Minocycline orally 100 mg twice/day for 10 weeks
Drug: Armodafinil
150 mg by mouth once a day for a 10 week cycle.
Other Name: Nuvigil
Drug: Minocycline
100 mg by mouth twice a day for a 10 week cycle.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn
Behavioral: Questionnaires
Completion of symptom questionnaire before chemoradiation, then once a week during Weeks 1-16, takes up to 5 minutes to complete.
Other Name: Surveys
Placebo Comparator: Placebos
Placebo Capsules orally once/day for 10 weeks
Other: Placebo
Capsules taken by mouth once a day for a 10 week cycle.
Other Name: Sugar Pill
Behavioral: Questionnaires
Completion of symptom questionnaire before chemoradiation, then once a week during Weeks 1-16, takes up to 5 minutes to complete.
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 concurrent chemoradiation therapy at MD Anderson.
  2. Patients > or =18 years old
  3. Patients who will receive chemoradiation with platinum/taxane-based chemotherapy and with a total radiation dose of > 50 Gy, per treating physician's assessment
  4. Patients who speak English or Spanish (due to the novel research and its complexity, we are only accruing English or Spanish-speaking patients to the protocol)
  5. Patients must be willing and able to review, understand, and provide written consent before starting therapy

Exclusion Criteria:

  1. Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions, as determined by the treating physician
  2. Patients who are enrolled in other symptom management or treatment clinical trials
  3. Patients currently taking methylphenidate and/or dextroamphetamine.
  4. Patients with a history of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction as documented in the patient medical records
  5. Patients with pre-existing psychosis or bipolar disorder.
  6. Patients with pre-existing renal impairment: The screening cut off for serum creatinine >1.5 times ULN, according to MD Anderson testing standards, will be done by the oncologist to qualify for CXRT.
  7. Patients with pre-existing hepatic impairment: The screening for total bilirubin >1.5 times ULN will be done by the oncologist to qualify for CXRT. The screening for > 2 times the upper limit of normal hepatotoxicity, alkaline phosphatase (ALP) and alanine aminotransferase (ALT) (and aspartate aminotransferase [AST] if it is ordered and available in the medical records) will be done by the oncologist to qualify for CXRT.
  8. Patients with pre-existing Tourette's syndrome.
  9. Patients with hypersensitivity to any tetracyclines.
  10. Patients who are pregnant. Pregnancy will be confirmed by negative urine test. Study staff will provide the pregnancy kits to women and make sure the results are known and recorded in the follow-up notes in Clinic Station before additional study drug prescriptions are filled by the Pharmacy
  11. Patients with uncontrolled cardiac disease, within the past six months history of left ventricular hypertrophy, myocardial infarction, and history of mitral valve prolapse syndrome with previous CNS stimulant use .
  12. Patients taking medicines that are strong CYP3A4 inhibitors or inducers (including conivaptan, indinavir, nelfinavir, ritonavir, nefazodone, and phenytoin), or strong CYP2C19 inhibitors (including citalopram and clopidogrel) .
  13. Patients on vitamin K antagonist warfarin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317550

Locations
United States, Texas
UT MD Anderson Cancer Center
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: NCT01317550     History of Changes
Other Study ID Numbers: 2010-0872, R01 026582-26, NCI-2011-00778
Study First Received: March 16, 2011
Last Updated: March 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
NSCLC
Symptoms
Concurrent Chemoradiation
CXRT
Fatigue
Pain
Disturbed Sleep
Lack of Appetite
Drowsiness
Armodafinil
Nuvigil
Minocycline
Dynacin
Minocin
Minocin PAC
Myrac
Solodyn
Placebo

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Minocycline
Modafinil
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Stimulants
Physiological Effects of Drugs
Central Nervous System Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 15, 2014