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

Pseudomyxoma Peritonei Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02387203
• Other study ID #: MMC-2014-53
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Mercy Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Appendiceal Neoplasms
• Pseudomyxoma Peritonei

Intervention

Drug:
• PrevPac (Prevacid, Amoxicillin, Clarithromycin)
30mg Prevacid, 1g amoxicillin, 500mg clarithromycin administered together for oral use, twice daily for 14 days preoperatively and twice daily for 14 days at least 4 weeks postoperatively

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tolerance and safety of PrevPac administration	Rate of morbidity and mortality	Through 14 day treatment therapy
Other	Analyze number of live bacteria in PMP tumor and mucin	In situ hybridization [ISH], either bright light or fluorescence in situ hybridization [FISH]	through study completion, an average of 5 years
Primary	Overall survival	Kaplan-Meier survival estimates	5 year
Secondary	Progression-free survival measured by no evidence of disease progression, i.e. tumor markers within normal limits, no radiographical evidence of disease	Kaplan-Meier survival estimates	5 year