Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Minocycline; Placebo; Questionnaires; Sensory Test
Intervention description: 200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for 4 months beginning at chemotherapy initiation.; 1 placebo by mouth for the first day of chemotherapy, then 1 dose every 12 hours for 4 months beginning at chemotherapy initiation.; Completion of questionnaires at baseline, 1 time each week, at each chemo cycle, at end of treatment visit, and at 6 month follow up visit.; Sensory test performed at baseline, 2 months, end of treatment visit, and at 6 month follow up visit.
Intervention MeSH terms: Minocycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colorectal cancer; CRC; Acute peripheral neuropathy; Numbness; Pain; Loss of motor function; Minocycline; Dynacin; Minocin; Minocin PAC; Myrac; Solodyn; Placebo; Questionnaires; Surveys; Sensory tests

Summary:

      The goal of this clinical research study is to learn if minocycline can reduce numbness,
      pain, and/or loss of motor function in patients with colorectal cancer. In this study,
      minocycline will be compared to a placebo.

      The study doctor can explain how the study drug is designed to work.

      A placebo is not a drug. It looks like the study drug, but it 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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a pathologically proven diagnosis of CRC seen either at MD Anderson or
             LBJ.

          2. Patients > or = 18 years old.

          3. Patients who qualify for oxaliplatin-based chemotherapy (in the adjuvant or metastatic
             setting) and are likely to receive at least 3 months of oxaliplatin.

          4. Patients who speak English or Spanish (due to language options for the MDASI version
             being used in this study, we are only recruiting English-speaking or Spanish-speaking
             patients).

          5. Patients with an NCI-CTCv4 sensory neuropathy score of 0.

          6. Patients with adequate renal function (serum creatinine must be < 1.5 times the upper
             limit of the institutional normal range) and no prior renal disease that in the
             opinion of the attending physician would make the patient ineligible to receive the
             study drug . Test results must be no more than 3 months old.

          7. Patients with adequate hepatic function (total bilirubin must be < 2.0 times the upper
             limit of the institutional normal range; alanine aminotransferase (ALT) and aspartate
             aminotransferase (AST) must be < 3.0 times the upper limit of the institutional normal
             range). Test results must be no more than 3 months old.

          8. Patients willing and able to review, understand, and provide written consent.

        Exclusion Criteria:

          1. Patients continuously taking any minocycline within the last 15 days. Patients who
             have conditions that potentially preclude use of minocycline as determined by the
             treating physician.

          2. Patients continuously taking systemic steroids within the last 15 days.

          3. Patients with autoimmune disorders (for example, systemic lupus erythematosus or
             rheumatoid arthritis), who have been treated in the last 3 years.

          4. Patients who are pregnant; the absence of pregnancy will be confirmed by negative
             urine test.

          5. Hypersensitivity to any tetracyclines, or a history of other allergies or drug
             reactions that in the treating physician's judgment make the patient inappropriate for
             this study.

          6. Patients receiving vitamin K antagonist (warfarin).

          7. Patients with a BMI >40 (Obese Class III criteria).

          8. Patients who will receive cetuximab or other targeted therapy where physicians may use
             topical doxycycline to reduce the rash associated with therapy.