Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
NCT ID:
NCT02775695
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:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02775695
Study Brief:
Protocol Section:
NCT02775695