Minocycline Hydrochloride in Reducing the Side Effects of Chemotherapy in Patients with Pancreatic Cancer
This trial is active, not recruiting.
|Treatments||minocycline, placebo, questionnaires|
|Sponsor||M.D. Anderson Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||January 2013|
|End date||January 2017|
|Trial size||76 participants|
|Trial identifier||NCT01693523, 1R21CA158902-01A1, 2012-0587, NCI-2012-02063|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Symptom Reduction During FOLFIRINOX Chemotherapy
time frame: 6 weeks
Changes Between Inflammation Biomarkers and Symptom Outcomes
time frame: 3 weeks
Male or female participants at least 18 years old.
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.
|Official title||A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden for Pancreatic Cancer Patients|
|Principal investigator||David Fogelman, MD|
|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.|
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