Phase 2
Completed N=79
Minocycline Study in Pancreatic Cancer Patients
Source: ClinicalTrials.gov NCT01693523 ↗Enrolled (actual)
79
Serious AEs
4.6%
Results posted
Feb 2020
Primary outcomePrimary: Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms — 51.5; 30.6; 36.2 Units on a scale *days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms |
51.5; 30.6; 36.2 | — |
| SECONDARY Relationship Between Dynamic Changes in Inflammation Biomarkers and Symptom Outcomes, Controlling for the Grouping Variables (Tumor Markers, Weight Loss), Evidence of Infection, ECOG PS, Age and Gender Examined |
— | — |
Eligibility Criteria
Inclusion Criteria
- Minocycline Trial only: Patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX or gemcitabine-based chemotherapy.
- Observational Arm only: Patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX chemotherapy.
- Patients > 18 years old.
- Minocycline Trial only: Patients with ECOG PS = 0-2.
- Patients who speak English or Spanish (due to MDASI language options, we are only accruing English-speaking or Spanish-speaking patients to the protocol).
- Patients willing and able to review, understand, and provide written consent before starting therapy.
- Minocycline Trial only: Patients with adequate renal function according to MD Anderson testing standards (screening cut off for serum creatinine 1.5.
- Patients who, in the judgment of the investigator, may be unable to participate in the required study procedures.
- 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.
Data sourced from ClinicalTrials.gov (NCT01693523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.