Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Minocycline in Oropharynx Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01173692
First received: July 29, 2010
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

The goal of this clinical research study is to learn if minocycline can reduce the symptoms reported by patients with oropharynx cancer, nasopharynx cancer, or unknown primary cancer of head and neck, who receive treatment with radiation therapy.


Condition Intervention Phase
Oropharynx Cancer
Drug: Minocycline
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Minocycline for Reduction of Radiation Therapy Treatment-Related Symptom Burden in Oropharynx Cancer: A Randomized Study.

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Combined AUC for Selected Patient Symptoms [ Time Frame: 7 weeks. They will take the study drug/placebo for up to 7 weeks and continue to complete the symptom survey until 15 weeks. ] [ Designated as safety issue: No ]
    7-week (+/- 5 days) area under the curve (AUC) for select MDASI-HNC symptoms namely fatigue, pain, sleep disturbance, difficulty swallowing and lack of appetite reported in the symptom survey.


Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Twice Daily Orally
Drug: Placebo
Twice daily by mouth, every day for 7 weeks starting at first day of radiation therapy.
Other Name: Sugar Pill
Experimental: Minocycline
100 mg Twice Daily Orally
Drug: Minocycline
100 mg twice daily (200 mg) by mouth , every day for 7 weeks starting first day of radiation therapy.
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn

  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 oropharyngeal cancer, nasopharyngeal cancer, or unknown primary cancer of head and neck in MDACC receiving radiation therapy with or without induction chemotherapy.
  2. Patients > = 18 years old.
  3. Patients with the above cancers, T0, TX, T1 to T3, N any, M0 receiving IMRT (to unilateral or bilateral neck) at least 64-72 Gy in 6-7 weeks as definitive treatment.
  4. Patients must have normal renal function test and no prior renal disease: The screening cut off for serum creatinine < upper limit of normal.
  5. Patients must have normal hepatic function test and no prior liver disease: The screening results for total bilirubin must be < 1.5 times the upper limit of normal. The screening results for the following must be < 2 times the upper limit of normal for patients to be eligible: Alkaline phosphatase (ALP) and Alanine aminotransferase (ALT). The screening results for Aspartate aminotransferase (AST) must be < 2 times the upper limit of normal if available.
  6. Patients who speak English (due to the novel research and its complexity, we are only accruing English speaking patients to the protocol).
  7. Patients must be willing to discontinue taking dong quai and/or St John's wort.
  8. Patients must be willing and able to review, understand, and provide written consent.

Exclusion Criteria:

  1. Patients receiving concurrent chemotherapy or concurrent biologic agent.
  2. Patients who are taking medications or have conditions that potentially preclude use of any study medications or interventions as determined by the treating physician.
  3. Patients who are enrolled in another symptom management trial or receiving active treatment under another clinical trial.
  4. Bile duct obstruction or cholelithiasis.
  5. History of clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reaction.
  6. Pre-existing psychosis or bipolar disorder.
  7. Hypersensitivity to any tetracyclines.
  8. Patients on anticoagulants (ie warfarin/heparin).
  9. Patients with INR > 1.5.
  10. Patients taking any tetracycline within the last 15 days.
  11. Patients that are pregnant.
  12. Patients treated with upfront radical surgery at the primary site (other than diagnostic tonsillectomy or excision).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173692

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: Gary B. Gunn, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01173692     History of Changes
Other Study ID Numbers: 2010-0096, CA07
Study First Received: July 29, 2010
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Oropharynx Cancer
Radiation Therapy
XRT
Radiotherapy
Minocycline
Symptoms
Head and Neck

Additional relevant MeSH terms:
Oropharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014