Phase II Study of Minocycline for Reducing Symptom Burden in Colorectal Patients

NCT01906008 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2013-0323NCI-2014-01291RSG-13-241-01-PCSM
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colorectal Cancer

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

Outcome Measures

Primary Outcomes (1)

• Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months

  AUC for MDASI-numbness/tingling . 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. For this study, the sub scale is the average of the 2 preselected items namely, numbness/tingling and fatigue. This subscale ranges from 0 to 10. The primary outcome is the average of the 120 -day area (4 months) under the curve for the sub scale. AUC ranges from 0 (0\*120) to 1200 (10\*120). To put this into perspective, the average AUC of 103.5 can also be thought of as an average daily AUC of 0.86 ( 103.5/120) on a 0 to 10 scale over the 120-day study period. Lower values represent better outcome while higher values represent worse outcome.

  Baseline to 4 months

Secondary Outcomes (1)

• Average Area Under the Curve (AUC) for Fatigue Over 4 Months

  Baseline to 4 months

Study Arms (2)

Minocycline

EXPERIMENTAL

Group 2 receives minocycline 200 mg orally for the first dose, then 100 mg orally 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.

Drug: Minocycline; Behavioral: Questionnaires; Behavioral: Sensory Test

Placebo

PLACEBO COMPARATOR

Group 1 receives a placebo 200 mg orally for the first day of chemotherapy, then 100 mg doses 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.

Drug: Placebo; Behavioral: Questionnaires; Behavioral: Sensory Test

Interventions

Minocycline DRUG

200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for 4 months beginning at chemotherapy initiation.

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

Minocycline

Placebo DRUG

1 placebo by mouth for the first day of chemotherapy, then 1 dose every 12 hours for 4 months beginning at chemotherapy initiation.

Placebo

Questionnaires BEHAVIORAL

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.

Also known as: Surveys

Minocycline; Placebo

Sensory Test BEHAVIORAL

Sensory test performed at baseline, 2 months, end of treatment visit, and at 6 month follow up visit.

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 CRC seen either at MD Anderson or LBJ.
• Patients \> or = 18 years old.
• Patients who qualify for oxaliplatin-based chemotherapy (in the adjuvant or metastatic setting) and are likely to receive at least 3 months of oxaliplatin.
• 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).
• Patients with an NCI-CTCv4 sensory neuropathy score of 0.
• 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.
• 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.
• Patients willing and able to review, understand, and provide written consent.

You may not qualify if:

• 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.
• Patients continuously taking systemic steroids within the last 15 days.
• Patients with autoimmune disorders (for example, systemic lupus erythematosus or rheumatoid arthritis), who have been treated in the last 3 years.
• Patients who are pregnant; the absence of pregnancy will be confirmed by negative urine test.
• 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.
• Patients receiving vitamin K antagonist (warfarin).
• Patients with a BMI \>40 (Obese Class III criteria).
• Patients who will receive cetuximab or other targeted therapy where physicians may use topical doxycycline to reduce the rash associated with therapy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (2)

LBJ Hospital

Houston, Texas, 77030, United States

Location

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

Colorectal Neoplasms; Hypesthesia; Pain; cyclopia sequence

Interventions

Minocycline; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; 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: Dr. James Yao, MD, Director of GI Medical Oncology
• Organization: UT MD Anderson Cancer Center

jyao@mdanderson.org

(713) 792-2828

Study Officials

• Cathy Eng, MD, BA

  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 18, 2013
• First Posted: July 23, 2013
• Study Start: November 1, 2013
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: March 17, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-03

Locations

US (2)