Phase I Trial HIPEC With Nal-irinotecan

The purpose of this study is to assess the effectiveness and safety of intraperitoneal administration of heated nanoliposomal Irinotecan in cytoreductive surgery (CRS), which is surgery designed to remove as much of the cancer as possible, and heated intraperitoneal chemotherapy (HIPEC) procedures.

Primary Outcome Measures

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 12 weeks post surgery ]To assess the safety and feasibility of administering nanoliposmal irinotecan intraperitoneally following cytoreductive surgery.

Secondary Outcome Measures

  1. Plasmatic dosages [ Time Frame: 48 hours ]Determine the correlation of intraperitoneal dosages of nanoliposomal irinotecan with plasma blood levels using pharmacokinetic analysis
  2. Disease free survival [ Time Frame: every 3-6 month until disease progression ]Assess the efficacy of intraperitoneal administration of nanoliposomal irinotecan relating to disease free survival.

Inclusion Criteria

  1. Patients with pseudomyxoma peritonei or peritoneal carcinomatosis of digestive origin or primary peritoneum: appendiceal mucinous tumor or adenocarcinoma (including goblet cell cancer and signet ring cell cancer), colorectal cancer, gastric cancer, primary peritoneal adenocarcinoma, and mesothelioma, regardless of the number of prior treatment lines. Clinical diagnosis is required prior to surgery and pathologic diagnosis of peritoneal surface disease must be confirmed from surgical pathology.
  2. Age ≥18 years
  3. Eastern Cooperative oncology Group performance status of 0 or 1
  4. Patients must be candidates for grossly complete cytoreduction surgery (i.e., completeness of cytoreduction score 0) with life expectancy greater than 3 months
  5. Patients must have normal organ and marrow function as defined below:
    • absolute neutrophil count >1,500/microliter (mcL) and white blood cells > 4000/mm3
    • platelets >75,000/microliters
    • total bilirubin < 3x upper limit normal for institutional limits
    • aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) <2.5x institutional upper limit of normal
    • creatinine within normal institutional limits
  6. Documentation of measurable disease by radiographic peritoneal carcinomatosis index (PCI) score and RECIST criteria with preoperative measurements taken within 4 weeks of study entry. Presence of measurable disease is required for entry into this study.
  7. Women of child-bearing potential and men must agree to use adequate contraception (barrier or hormonal plus barrier method of birth control; abstinence) prior to study entry and for the duration of study participation (at least first 6 months). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  1. Patients with peritoneal disease considered to be unresectable according to preoperative clinical criteria.
  2. Patients who undergo debulking for palliation with persistence of gross residual disease (complete of cytoreduction score 3, CC=3) will be ineligible for the study.
  3. Large burden visceral metastases or extra-abdominal metastases.
  4. Patients who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. There is no limit on the number of prior lines of chemotherapy.
  5. Patients may not be receiving any other investigational agents.
  6. History of allergic reactions to nal-IRI or irinotecan.
  7. Uncontrolled ongoing illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  8. Pregnant or breast-feeding women are excluded from this study.
  9. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.

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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: October 4th, 2019.

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Last update: May 07, 2019. 08:38:48 pm.