Minocycline Study in Pancreatic Cancer Patients
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Minocycline; Placebo; Questionnaires
Intervention description: 100 mg by mouth two times a day (200 mg/day).; Matching placebo capsules by mouth twice a day.; Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study 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: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Cancer; Pancreatic adenocarcinoma; Locally advanced; Metastatic disease; Symptom reduction; Minocycline; Dynacin; Minocin; Minocin PAC; Myrac; Solodyn; Placebo; Sugar Pill; Questionnaires; Surveys

Summary:

      The goal of this clinical research study is to learn if minocycline can reduce the side
      effects of chemotherapy in patients with pancreatic cancer. In this study, minocycline will
      be compared to a placebo.

      Minocycline is an antibiotic that may help to reduce side effects of chemotherapy.

      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. 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.