Antibiotic Treatment and Long-term Outcomes of Patients With Pseudomyxoma Peritonei of Appendiceal Origin

Age Range:21 - Any
Start Date:January 2015
End Date:December 2021
Contact:Michelle Sittig, RN

Use our guide to learn which trials are right for you!

Clinical Trial to Define the Effect of Perioperative H. Pylori Eradication With Antibiotic Treatment on the Long Term Outcomes of Patients With Pseudomyxoma Peritonei of Appendiceal Origin Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (CRS/HIPEC)

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).

Single center, open label, historical controlled, phase II study that proposes two courses
of standard H. Pylori eradication antibiotic therapy can suppress carcinogenesis and improve
the long-term outcomes of patients with PMP. The first course of antibiotics (PrevPac) will
be administered before cytoreductive surgery and HIPEC and the second course afterwards. The
historical control group will consist of all PMP patients from Mercy Medical Center's Tumor
Registry who did not receive perioperative antibiotic treatment. Long-term statistical
outcomes will be calculated using the Kaplan-Meier method and Cox proportional hazard ratio
to compare pertinent variable. 80 subjects to be enrolled over 2 years, with a 5 year
follow-up period.

Inclusion Criteria:

- Patients must have measurable pseudomyxoma peritonei from appendiceal origin,
confirmed by histology, cytology, or radiographical evidence -

- Age ≥ 21 years

- Eastern Cooperative Onocology 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

Hepatic function:

Bilirubin ≤1.5 times ULN ALT ≤3 times ULN 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

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 PREVPAC is based on the pregnancy category for
clarithromycin which is Category C agent with the potential for teratogenic or
abortifacient effects. These potential risks may also apply to CRS/HIPEC.

- Assessed by the investigator to be unable or unwilling to comply with the
requirements of the protocol (e.g., unable to swallow pills)

- Psychiatric or addictive disorders or other conditions that, in the opinion of the
investigator, would preclude the patient from meeting the study requirements or
giving informed consent

- Known active acute hepatitis and confirmed diagnosis of Human Immunodeficiency Virus
(HIV) infection. HIV-positive patients on combination antiretroviral therapy are
ineligible. These patients are at increased risk of lethal infections when treated
with marrow-suppressive therapy.

- Active systemic infection that requires use of parenteral antibiotics

- Renal insufficiency with serum creatinine level ≥1.5 times the upper limit of normal
or calculated -

- Patients with concurrent severe medical problems unrelated to malignancy that will
preclude compliance with the study or places at an unacceptable risk for
participation in the study determinate by study investigators

- Patients to be maintained on any medication having severe interactions with PREVPAC
We found this trial at
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
Baltimore, MD
Click here to add this to my saved trials