Phase I Trial HIPEC With Nal-irinotecan (NCT04088786) | Clinical Trial Compass
CompletedPhase 1
Phase I Trial HIPEC With Nal-irinotecan
United States18 participantsStarted 2019-10-22
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. 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. Diagnosis of peritoneal metastasis to be confirmed via either clinical or histopathology assessment.
ā. Age ā„18 years
ā. Eastern Cooperative Oncology Group performance status of 0 or 1
ā. Patients must be candidates for grossly complete cytoreduction surgery with life expectancy greater than 3 months
ā. Patients must have normal organ and marrow function as defined below:
ā. Documentation of resectable disease extent by radiographic peritoneal carcinomatosis index (PCI) score or preoperative diagnostic surgery/laparoscopy with preoperative measurements taken within 6 weeks of study entry.
ā. 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.
ā. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
ā. Patients with peritoneal disease considered to be unresectable according to preoperative clinical criteria.
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
ā. 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.
ā. Large burden visceral metastases or extra-abdominal metastases.
ā. 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.
ā. Patients may not be receiving any other investigational agents.
ā. History of allergic reactions to nal-IRI or irinotecan.