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Phase 2 Completed N=12 Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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