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

NCT02387203 | Active Not Recruiting Phase 2

• 1 other identifier: MMC-2014-53
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Pseudomyxoma Peritonei; Appendiceal Neoplasms

Keywords

Pseudomyxoma Peritonei; Appendiceal cancer; CRS/HIPEC; PMP

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Kaplan-Meier survival estimates

  5 year

Secondary Outcomes (1)

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

  5 year

Other Outcomes (2)

• Tolerance and safety of PrevPac administration

  Through 14 day treatment therapy

• Analyze number of live bacteria in PMP tumor and mucin

  through study completion, an average of 5 years

Study Arms (2)

PrevPac

EXPERIMENTAL

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.

Drug: PrevPac (Prevacid, Amoxicillin, Clarithromycin)

PMP Historical Control

NO INTERVENTION

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

Interventions

PrevPac (Prevacid, Amoxicillin, Clarithromycin) DRUG

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

Also known as: PREVPAC, U.S. Patent No. 5,013,743

PrevPac

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Medical Center: lead

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Pseudomyxoma Peritonei; Appendiceal Neoplasms

Interventions

Lansoprazole; Amoxicillin; Clarithromycin

Condition Hierarchy (Ancestors)

Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Armando Sardi, M.D.

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

• Scott Merrell, PhD

  Uniformed Sciences University, Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: March 12, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

US (1)