Minocycline Study in Pancreatic Cancer Patients

• Status: Completed
• Trial end date: 2018-09-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Minocycline

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.