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

Primary Purpose

Pseudomyxoma Peritonei, Appendiceal Neoplasms

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PrevPac (Prevacid, Amoxicillin, Clarithromycin)

About this trial

This is an interventional treatment trial for Pseudomyxoma Peritonei focused on measuring Pseudomyxoma Peritonei, Appendiceal cancer, CRS/HIPEC, PMP

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mercy Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PrevPac

PMP Historical Control

Arm Description

Study intervention: PrevPac (Prevacid, Amoxicillin, Clarithromycin)twice daily x 14 days for 2 courses (preoperative and post-operative). All eligible patients with a PMP diagnosis, undergoing CRS/HIPEC treatment, who consent to study participation will have a urea breath test prior to the first course of PrevPac. After surgery, when tolerated, each patient will take a second course of PrevPac. Patients will be seen for follow-up as clinically indicated until year 5.

The historical control group will consist of all PMP patients who did not receive perioperative antibiotic treatment.

Outcomes

Primary Outcome Measures

Overall survival

Kaplan-Meier survival estimates

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02387203

First Posted

January 19, 2015

Last Updated

March 13, 2023

Sponsor

Mercy Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02387203

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 2015 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mercy Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pseudomyxoma Peritonei, Appendiceal Neoplasms

Keywords

Pseudomyxoma Peritonei, Appendiceal cancer, CRS/HIPEC, PMP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PrevPac

Arm Type

Experimental

Arm Description

Arm Title

PMP Historical Control

Arm Type

No Intervention

Arm Description

The historical control group will consist of all PMP patients who did not receive perioperative antibiotic treatment.

Intervention Type

Drug

Intervention Name(s)

PrevPac (Prevacid, Amoxicillin, Clarithromycin)

Other Intervention Name(s)

PREVPAC, U.S. Patent No. 5,013,743

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival

Description

Kaplan-Meier survival estimates

Time Frame

5 year

Secondary Outcome Measure Information:

Title

Progression-free survival measured by no evidence of disease progression, i.e. tumor markers within normal limits, no radiographical evidence of disease

Description

Kaplan-Meier survival estimates

Time Frame

5 year

Other Pre-specified Outcome Measures:

Title

Tolerance and safety of PrevPac administration

Description

Rate of morbidity and mortality

Time Frame

Through 14 day treatment therapy

Title

Analyze number of live bacteria in PMP tumor and mucin

Description

In situ hybridization [ISH], either bright light or fluorescence in situ hybridization [FISH]

Time Frame

through study completion, an average of 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Armando Sardi, M.D.

Organizational Affiliation

Mercy Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Scott Merrell, PhD

Organizational Affiliation

Uniformed Sciences University, Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mercy Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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