Antibiotic Treatment and Long-term Outcomes of Patients With Pseudomyxoma Peritonei of Appendicea… (NCT02387203) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Antibiotic Treatment and Long-term Outcomes of Patients With Pseudomyxoma Peritonei of Appendiceal Origin
United States80 participantsStarted 2015-01
Plain-language summary
The purpose of this study is to determine the impact of antibiotic therapy on the disease progression and overall survival of patients with Pseudomyxoma Peritonei (PMP).
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have measurable pseudomyxoma peritonei from appendiceal origin, confirmed by histology, cytology, or radiographical evidence -
* Age ≥ 21 years
* Eastern Cooperative Oncology Group (ECOG) performance status score≤2/Karnofsky performance status of (KPS) ≥ 70% (see Appendix B)
* Patients must have normal organ and marrow function as defined below:
Absolute neutrophil count (ANC) ≥1,000/mm3 Platelets ≥100,000/mm3 Hemoglobin ≥ 8.5 g/dL
Renal function:
Creatinine ≤1.5 times the upper limit of normal (ULN) or calculated creatinine clearance ≥60ml/min
Hepatic function:
Bilirubin ≤1.5 times ULN Alanine aminotransferase (ALT) ≤3 times ULN Aspartate aminotransferase (AST) ≤3 times ULN
* Ability of subject or Legally Authorized Representative (LAR) to understand and willingness to sign a written informed consent, approved by Mercy Medical Center Institutional Review Board (IRB)
* A negative pregnancy test for women of childbearing age with all reproductive organs intact
Exclusion Criteria:
* Patients receiving any other investigational agents
* Presence of other invasive malignancies or evidence of another cancer present within the last 3 years, excluding skin cancer
* history of, or known allergic reaction/hypersensitivity to PREVPAC or any component of similar chemical or biologic composition to PREVPAC
* Patients \< 21 of age
* Pregnancy or lactation at the time of proposed assignment. Pregnant women are excluded from this study because PR…