Phase 2
Completed N=12
Efficacy of Doxycycline on Metakaryote Cell Death in Patients With Resectable Pancreatic Cancer
Source: ClinicalTrials.gov NCT02775695 ↗Enrolled (actual)
12
Serious AEs
75.0%
Results posted
Jul 2023
Primary outcomePrimary: Determine the Efficacy of Doxycycline in Inducing Metakaryotic Cell Death in Primary Pancreatic Tumors as Measured by Pathologic Response — 8.9 Cells/g
Summary
This is a window-of-opportunity study that examines the efficacy of doxycycline, and FDA-approved oral antibiotic, on metakaryotic (cancer stem cells) in resectable pancreatic cancer following eight weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Efficacy of Doxycycline in Inducing Metakaryotic Cell Death in Primary Pancreatic Tumors as Measured by Pathologic Response |
8.9 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed pancreatic adenocarcinoma which may be acquired using a fine needle aspiration.
- Not received any prior therapy.
- Established resectable pancreatic cancer based on radiographic imaging.
- Patients who will receive neoadjuvant therapy (chemoradiation) are eligible.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).
- Have no active or chronic infection with HIV, Hepatitis B or Hepatitis C
- Life expectancy of greater than six months.
- Ability to understand and the willingness to sign a written informed consent document.
- Normal organ and marrow function as defined below:
- leukocytes ≥3,000/microliter (mcL)
- absolute neutrophil count ≥1,500/mcL
- platelets ≥100,000/mcL
- total bilirubin < 2 mg/dL or has demonstrated progressive decline within two weeks of biliary decompression to allow for appropriate gemcitabine dose modification.
- Aspartate Aminotransferase (AST)[Serum Glutamic Oxaloacetic Transaminase (SGOT] )/ Alanine Aminotransferase (ALT) [Serum Glutamic Pyruvic Transaminase(SGPT)] ≤3 × institutional upper limit of normal
- Creatinine clearance ≥60 mL/min/1.73 m^2
Exclusion Criteria
- Patients with more clinically advanced pancreatic cancer (borderline resectable, locally advanced, or metastatic).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because the effects of metakaryocidal agents have the potential for teratogenic or abortifacient effects.
- Previous history of other malignancy (other than cured basal or squamous cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within two years of study enrollment.
- Active or chronic HIV, hepatitis B or hepatitis C.
- Patients who are receiving other investigational drugs or enrolled in other clinical trials.
- Inability to undergo scheduled blood acquisition per protocol.
- Drug specific exclusion including history of allergic reactions to tetracyclines.
- Prior treatment with doxycycline within a seven day washout period prior to initiating treatment with alternate antimetakaryocidal medication.
Data sourced from ClinicalTrials.gov (NCT02775695). 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.