Efficacy of Doxycycline on Metakaryote Cell Death in Patients With Resectable Pancreatic Cancer

• Status: Active, not recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Doxycycline

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:

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.