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Anti-bacterial

Antibiotic Therapy for Pseudomyxoma Peritonei

Phase 2

Waitlist Available

Led By Armando Sardi, M.D.

Research Sponsored by Mercy Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hepatic function: Bilirubin ≤ 1.5 times ULN, ALT ≤ 3 times ULN, AST ≤ 3 times ULN

A negative pregnancy test for women of childbearing age with all reproductive organs intact

Must not have

Presence of other invasive malignancies or evidence of another cancer present within the last 3 years, excluding skin cancer

Known active acute hepatitis and confirmed diagnosis of Human Immunodeficiency Virus (HIV) infection. HIV-positive patients on combination antiretroviral therapy are ineligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 year

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial will study whether antibiotic therapy can improve the disease progression and overall survival for patients with Pseudomyxoma Peritonei.

Who is the study for?

Adults over 21 with Pseudomyxoma Peritonei from appendiceal origin can join this trial. They must have good kidney and liver function, no severe unrelated medical issues, not be pregnant or breastfeeding, able to swallow pills, and not on conflicting medications. HIV-positive patients or those with active infections requiring IV antibiotics are excluded.

What is being tested?

The study is testing the effects of an antibiotic regimen called PrevPac (Prevacid, Amoxicillin, Clarithromycin) on disease progression and survival in patients with Pseudomyxoma Peritonei. It aims to see if these antibiotics can improve long-term outcomes for these patients.

What are the potential side effects?

Possible side effects of PrevPac may include digestive problems like nausea and diarrhea, changes in taste sensation, headache, skin reactions such as rash or itching. More serious but less common side effects could involve liver problems or a severe allergic reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver tests are within the required limits.

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I am not pregnant and of childbearing age.

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I am 21 years old or older.

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My cancer originates from the appendix and can be measured by tests.

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I am mostly self-sufficient and can carry out daily activities.

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My blood tests show normal organ function and healthy blood cell counts.

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My kidney function is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any other cancer besides skin cancer in the last 3 years.

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I do not have active hepatitis or HIV, or if I have HIV, I am not on antiretroviral therapy.

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I am younger than 21 years old.

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I am currently on IV antibiotics for an infection.

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My kidney function is reduced with high creatinine levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival

Secondary study objectives

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

Other study objectives

Analyze number of live bacteria in PMP tumor and mucin

Tolerance and safety of PrevPac administration

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PrevPacExperimental Treatment1 Intervention

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.

Group II: PMP Historical ControlActive Control1 Intervention

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

0 / 12Eligibility criteria met