Status:
COMPLETED
Study of Tamoxifen in Well Differentiated Neuroendocrine Tumors and Hormone Receptor Positive Expression
Lead Sponsor:
AC Camargo Cancer Center
Collaborating Sponsors:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Neuroendocrine Tumors
Progesterone Receptor Positive Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single-arm, unicentric, single-stage clinical study of tamoxifen for patients with well differentiated neuroendocrine tumors and radiological progression with positive (\> 1 percent) HR (est...
Detailed Description
Neuroendocrine tumors (NET) are rare neoplasms, but with increasing incidence and prevalence in the last decades. Although they may manifest in the most diverse tissues, the vast majority of cases wil...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years
- Histological diagnosis of well differentiated NET (typical and atypical lung carcinoids, NET G1, NET G2 of all gastroenteropancreatic sites and pancreatic NET G3 according to WHO 2017 classification) 20 advanced / metastatic, inoperable, with no possibility of curative treatment
- Immunohistochemical expression ≥ 1 percent for estrogen and / or progesterone receptor
- Disease with radiological progression (at least 10 percent tumor volume growth) in the last 12 months before day 1 cycle 1.
- No possibility of established treatments due to lack of access, risk of toxicities or without clinical indication. Patients who meet criteria for watchful waiting (low-dose disease and non-functioning NET) may be included.
- Measurable disease
- ECOG performance scale 0 to 2.
- Adequate organic function as defined by the following criteria:
- serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of local laboratory normality (LSN-LL);
- Total serum bilirubin ≤ 2.0 x ULN-LL;
- Absolute neutrophil count ≥ 1,500 / mm\^3;
- Platelet count ≥ 80,000 / mm\^3;
- Hemoglobin ≥ 9.0 g / dL;
- Estimated creatinine clearance by the MDRD equation ≥ 30ml / min
- Albumin ≥ 3.5 g / dL;
- INR ≤ 1.5
- Term of free and informed consent signed by the patient or legal representative.
Exclusion
- Patients already on tamoxifen, but other prior treatment are allowed
- Patients with aggressive disease requiring cytotoxic therapy or locoregional therapies (eg hepatic embolization)
- A history of serious clinical or psychiatric illness that, by clinical judgment, may involve participation risk in this study
- Patients participating in other protocols with experimental drugs.
- Patients with oral food difficulties.
- Patients who underwent major recent surgery less than 4 weeks previously.
- Patients receiving chemotherapy or other oncologic therapy for less than 3 weeks.
- Patients who use oral anticoagulation
- Previous history of deep vein thrombosis or pulmonary embolism in the last 12 months.
- Pregnant or lactating patients.
- Patients with postmenopausal vaginal bleeding with no defined etiology.
- Patients with breast cancer who need to use tamoxifen for this neoplasm
- Another synchronous neoplasm that requires systemic treatment
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03870399
Start Date
March 13 2019
End Date
May 13 2023
Last Update
May 6 2024
Active Locations (2)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
2
AC Camargo Cancer Center
São Paulo, São Paulo, Brazil, 01525000