Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic GEP-NET

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The current study is an investigator-initiated, single-arm phase 1/2 study that enrolled patients with advanced or recurrent and/or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma for the treatment of nal-IRI (ONIVYDE®) plus carboplatin as the first-line chemotherapy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Chang Gung Memorial Hospital; China Medical University Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital; National Cheng-Kung University Hospital; Taipei Veterans General Hospital, Taiwan
• Treatments: Carboplatin; Irinotecan

Criteria

Inclusion Criteria:

1. histologically confirmed locally advanced or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma.

2. patients either are chemotherapy-naive or had received adjuvant chemotherapy > 6 months before recurrence.

3. at least one measurable lesion according to the RECIST version 1.1..

4. patients were aged 20 to 80 years with ECOG performance status of 0 to 1.

5. patients had a life expectancy ≥ 3 months.

6. patients had adequate renal function with defined as serum creatinine ≤ 2 times the upper limit of normal (ULN) or eGFR (calculated Ccr) ≥ 45 mL/min.

7. patients had adequate hepatic function, defined as total bilirubin ≤ 1.5 times the ULN and alanine aminotransferase ≤ 2.5 the ULN and ≤ 5 times the ULN within the setting of liver metastases.

8. patients had adequate bone marrow function, defined as an absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 9 g/dL.

9. Normal ECG or abnormal ECG without any clinical significantly findings.

10. Able to understand and sign an informed consent (or have a legal representative who is able to do so).

Exclusion Criteria:

1. a history of palliative chemotherapy or disease recurrence < 6 months from the time of last adjuvant chemotherapy and/or radiotherapy.

2. known hypersensitivity to liposome product, irinotecan or carboplatin.

3. receipt of major surgery within the past 4 weeks before study enrollment.

4. With clinically significant gastrointestinal disorder including bleeding, inflammation, occlusion or diarrhea > grade 2.

5. concurrent severe infection with intravenous systemic antibiotics treatment.

6. severe, uncontrolled medical condition including severe liver disease, heart disease, uncontrolled diabetes or hypertension, or pulmonary disease.

7. another previous malignancy diagnosed within the past 5 years except for nonmelanoma skin cancer or stage I cervical cancer.

8. active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti-convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable.

9. psychiatric illness or social situation that would preclude study compliance

10. women with pregnant or breast feeding (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative).