Minocycline Study in Pancreatic Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01693523
First received: September 21, 2012
Last updated: January 5, 2015
Last verified: January 2015
  Purpose

The goal of this research study is to learn if pancreatic cancer and the FOLFIRINOX chemotherapy are associated with symptoms such as fatigue, pain, disturbed sleep, lack of appetite, and drowsiness, among others. Researchers also want to learn whether any symptoms you may have are related to markers of inflammation. Markers of inflammation are found in the blood and may be related to symptoms you may have.


Condition Intervention Phase
Pancreatic Cancer
Drug: Minocycline
Other: Placebo
Behavioral: Questionnaires
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden for Pancreatic Cancer Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Symptom Reduction During FOLFIRINOX Chemotherapy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Primary outcome variable for the study is area under the curve (AUC) value of 5 symptoms: fatigue, drowsiness, pain, disturbed sleep, and lack of appetite over 6 weeks. Estimates of treatment effect obtained using standard linear regression techniques in which AUC values are regressed on indicator variables that represent treatment received. AUC is calculated using a trapezoidal approximation. Area of trapezoid is derived by multiplying half of base with sum of two heights. Base is number of days in between two administration of M.D. Anderson Symptom Inventory (MDASI). Two heights correspond to two mean symptom scores computed at each of these assessments. AUC is measured in units of mean MDASI score in days. Area for subsequent trapezoid calculated in same way. AUC is sum of area of 6 trapezoids.


Secondary Outcome Measures:
  • Changes Between Inflammation Biomarkers and Symptom Outcomes [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Relationship between dynamic changes in inflammation biomarkers and symptom outcomes, controlling for the grouping variable, disease progression (tumor markers, weight loss), evidence of infection, ECOG PS, age, and gender examined. Regression analyses performed to examine relationship between AUC values/MDASI values and CRP, IL-6 and p38 intensity values. Analyses include linear regression analyses of AUC values on the three measured CRP, IL-6 and p38 intensity values, as well as longitudinal analyses of the relationship between individual symptom scores as measured by MDASI and CRP, IL-6, and p38 intensity variables. Using linear regression analyses, effects of minocycline treatment examined on each of the serum markers.


Estimated Enrollment: 76
Study Start Date: January 2013
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline
Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Drug: Minocycline
100 mg by mouth two times a day (200 mg/day).
Other Names:
  • Dynacin
  • Minocin
  • Minocin PAC
  • Myrac
  • Solodyn
Behavioral: Questionnaires
Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Other Name: Surveys
Placebo Comparator: Placebo
Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Other: Placebo
Matching placebo capsules by mouth twice a day.
Other Name: Sugar pill
Behavioral: Questionnaires
Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Other Name: Surveys

Detailed Description:

Study Visits:

If you agree to take part in this study, you will have the following:

At the time of enrollment:

  • You will complete 2 questionnaires about pain and other symptoms, and your quality of life. It should take about 3-5 minutes to complete the questionnaires.
  • If possible, blood (about 2 teaspoons) will be drawn to test for markers of inflammation at the same time you are having other routine blood draws.
  • Your demographic information, such as your marital status, job status, education, and race will be recorded as well as information about the disease and any treatment you have received.

During FOLFIRINOX treatment:

  • You will complete the symptom questionnaire 2 times each week during the first cycle and 1 time each week during any remaining cycles. The symptom questionnaire asks about any symptoms you may be having and how they may be affecting your daily activities. You will also complete the quality of life questionnaire.
  • You will complete the questionnaires in paper-and-pencil format or on an electronic tablet PC if you are in the clinic. When you are away from the clinic you will complete the questionnaires on the telephone or on your computer.
  • If possible, during any clinic visits at the start of cycle 2, 3, and 4 (if applicable), blood (about 2 teaspoons) will be drawn to test for markers of inflammation at the same time you are having other routine blood draws.

Length of Study Participation:

You will be on study for up to 8 weeks from the time your chemotherapy starts.

This is an investigational study.

Up to 45 patients will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Minocycline Trial only: Patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX or gemcitabine-based chemotherapy.
  2. Observational Arm only: Patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX chemotherapy.
  3. Patients > 18 years old.
  4. Minocycline Trial only: Patients with ECOG PS = 0-2.
  5. Patients who speak English or Spanish (due to MDASI language options, we are only accruing English-speaking or Spanish-speaking patients to the protocol).
  6. Patients willing and able to review, understand, and provide written consent before starting therapy.
  7. Minocycline Trial only: Patients with adequate renal function according to MD Anderson testing standards (screening cut off for serum creatinine < 2 times the upper limit of normal).
  8. Minocycline Trial only: Patients with adequate hepatic function according to MD Anderson testing standards (screening results for total bilirubin must be < 2 times the upper limit of normal; screening results for alanine aminotransferase (ALT) must be < 3 times the upper limit of normal; screening results for aspartate aminotransferase (AST), if available, must be < 3 times the upper limit of normal).

Exclusion Criteria:

  1. Minocycline Trial only: Patients who are taking medication or have conditions that potentially preclude use of minocycline, as determined by the treating physician.
  2. Patients who are enrolled in other symptom management clinical trials.
  3. Minocycline Trial only: Patients who currently have bile duct obstruction or cholelithiasis.
  4. Minocycline Trial only: Patients with hypersensitivity to any tetracyclines.
  5. Minocycline Trial only: Patients who are pregnant. Pregnancy will be confirmed by negative urine test; patients with a positive urine test will be retested for doubling of HCG 48 hours after the first test, because of beta-HCG's role as a tumor marker. Patients without such a rise will be eligible for the study and will be enrolled at the investigator's discretion.
  6. Minocycline Trial only: Patients who are under treatment of warfarin with INR > 1.5.
  7. Patients who, in the judgment of the investigator, may be unable to participate in the required study procedures.
  8. Minocycline Trial only: Patients who have had prior treatment for pancreatic cancer within the past six months may be excluded at the discretion of the investigator.
  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: NCT01693523

Contacts
Contact: David Fogelman, MD 713-745-3470

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: David Fogelman, MD M.D. Anderson Cancer Center
Principal Investigator: Shelley Wang, MD,MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01693523     History of Changes
Other Study ID Numbers: 2012-0587, 1R21CA158902-01A1, NCI-2012-02063
Study First Received: September 21, 2012
Last Updated: January 5, 2015
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
Pancreatic Cancer
Pancreatic adenocarcinoma
Locally advanced
Metastatic disease
Symptom reduction
Minocycline
Dynacin
Minocin
Minocin PAC
Myrac
Solodyn
Placebo
Sugar Pill
Questionnaires
Surveys

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 26, 2015