Minocycline Study in Pancreatic Cancer Patients
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: Minocycline (Drug); Placebo (Other); Questionnaires (Behavioral)
Phase: Phase 2
Status: Recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): David Fogelman, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center Shelley Wang, MD,MPH, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
Overall contact: David Fogelman, MD, Phone: 713-745-3470
Summary
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.
Clinical Details
Official title: A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden for Pancreatic Cancer Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Symptom Reduction During FOLFIRINOX Chemotherapy
Secondary outcome: Changes Between Inflammation Biomarkers and Symptom Outcomes
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
David Fogelman, MD, Phone: 713-745-3470
University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information
University of Texas MD Anderson Cancer Center Website
Starting date: January 2013
Last updated: July 9, 2015
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