Clinical trial · Interventional
Efficacy of Doxycycline on Metakaryote Cell Death in Patients With Resectable Pancreatic Cancer
NCT02775695CI-TRIAL-00067756completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Resectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxycycline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Doxycycline Administered to Patients
- description
- Patients will receive oral doxycycline and trough serum concentrations for pharmacokinetic studies will be obtained.
- interventionNames
- Drug: Doxycycline
Primary outcomes (1)
- measure
- Determine the Efficacy of Doxycycline in Inducing Metakaryotic Cell Death in Primary Pancreatic Tumors as Measured by Pathologic Response
- timeFrame
- Month 3 visit
- description
- The histopathologic response of the primary tumor will be assessed using the College of American Pathology criteria for residual tumor response following neoadjuvant therapy for the exocrine pancreas. Researchers will enumerate the number of observed dead/dying metakaryotes per 1 gram of resected pancreatic tissue.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: 1. leukocytes ≥3,000/microliter (mcL) 2. absolute neutrophil count ≥1,500/mcL 3. platelets ≥100,000/mcL 4. total bilirubin \< 2 mg/dL or has demonstrated progressive decline within two weeks of biliary decompression to allow for appropriate gemcitabine dose modification. 5. Aspartate Aminotransferase (AST)\[Serum Glutamic Oxaloacetic Transaminase (SGOT\] )/ Alanine Aminotransferase (ALT) \[Serum Glutamic Pyruvic Transaminase(SGPT)\] ≤3 × institutional upper limit of normal 6. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.