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

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ClinicalTrials.gov Identifier: NCT02387203
Recruitment Status : Recruiting
First Posted : March 12, 2015
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Mercy Medical Center

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).

Condition or disease Intervention/treatment Phase
Pseudomyxoma Peritonei Appendiceal Neoplasms Drug: PrevPac (Prevacid, Amoxicillin, Clarithromycin) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: PrevPac
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)
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
Other Name: PREVPAC, U.S. Patent No. 5,013,743
No Intervention: PMP Historical Control
The historical control group will consist of all PMP patients who did not receive perioperative antibiotic treatment.



Primary Outcome Measures :
  1. Overall survival measured by survival rates [ Time Frame: 1 year after diagnosis ]
  2. Overall survival measured by survival rates [ Time Frame: 3 years after diagnosis ]
  3. Overall survival measured by survival rates [ Time Frame: 5 years after diagnosis ]

Secondary Outcome Measures :
  1. Progression-free survival measured by no evidence of disease progression, i.e. tumor markers within normal limits, no radiographical evidence of disease [ Time Frame: at 1, 3, and 5 years after surgery ]

Other Outcome Measures:
  1. Tolerance and safety of PrevPac administration as measured by rate of morbidity and mortality [ Time Frame: Preoperatively and up to 12 weeks post-operatively ]
  2. Analyze and measure number of live bacteria in PMP tumor and mucin [ Time Frame: 3 years ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ≥60ml/min

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387203


Contacts
Contact: Michelle Sittig, RN 410-332-9294 msittig@mdmercy.com

Locations
United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Mercy Medical Center
Investigators
Principal Investigator: Armando Sardi, M.D. Mercy Medical Center
Principal Investigator: Scott Merrell, PhD Uniformed Sciences University, Health Sciences

Responsible Party: Mercy Medical Center
ClinicalTrials.gov Identifier: NCT02387203     History of Changes
Other Study ID Numbers: MMC-2014-53
First Posted: March 12, 2015    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Mercy Medical Center:
Pseudomyxoma Peritonei
Appendiceal cancer
CRS/HIPEC
PMP

Additional relevant MeSH terms:
Pseudomyxoma Peritonei
Appendiceal Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cecal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Cecal Diseases
Intestinal Diseases
Anti-Bacterial Agents
Amoxicillin
Clarithromycin
Antibiotics, Antitubercular
Lansoprazole
Dexlansoprazole
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents