An open-label, single arm, prospective, multi-center, tandem two stage designed, phase II study to evaluate the efficacy of Fulvestrant in women with recurrent/metastatic estrogen receptor positive gynecological malignancies
- Conditions
- low grade gynacological tumors10038594
- Registration Number
- NL-OMON50189
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Written informed consent prior admission to the study
Age >= 18 years at the moment of signing the informed consent
Recurrent or metastatic low grade uterine sarcomas, low-grade endometrial
carcinomas, sex cord stromal tumors and low grade serous ovarian cancer
Measurable disease, according to RECIST v1.1 criteria
ER-positive tumors based on immunohistochemistry, more than 10% of tumor cells
should be positive for ER. After the study, central analysis of ER staining
will be assessed using the Allred scoring system (based on intensity and
percentage of positive cells) and archival tissue (< 3 years old) available
1 or 2 prior lines of hormonal therapy
ECOG performance status: 0-2
Demonstrate adequate organ function
Post-menopausal status
Be willing to receive 18F-FES PET scan.
• Any other active malignancy or primary malignancy diagnosed within the
previous 5 years, except for adequately treated squamous or basal cell
carcinoma of the skin or in situ cervical carcinoma
• Patients currently receiving (and unwilling to discontinue) any estrogen
replacement therapy.
• Patients participating in a study or having participated in a study of an
investigational agent and received study therapy (or used an investigational
device) within 4 weeks prior to study Day 1
• Patients who received prior chemo- or targeted therapy within 4 weeks prior
to study Day 1 or who has not recovered from adverse events (i.e., adverse
event not resolved to <= Grade 1 or baseline), due to a previously administered
agent
• Patients with no archival tissue available, except for patients from whom an
additional fresh core biopsy can be obtained for ER assessment
• Any other disease, metabolic dysfunction, physical examination or clinical
laboratory finding that, in the investigator's opinion, gives reasonable
suspicion of a disease or condition that contraindicates the use of an
investigational drug, may affect the interpretation of the results, render the
patient at high risk from treatment complications or interfere with obtaining
informed consent.
• Any condition not permitting compliance with the study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the response rate (RR) upon Fulvestrant treatment, comprising<br /><br>either partial or complete response, as determined by RECIST v1.1 criteria, in<br /><br>each tumor type group</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To determine progression-free survival (PFS) upon Fulvestrant treatment,<br /><br>after 3 years, in each tumor type group<br /><br>• To assess duration of response in each tumor type group<br /><br>• To assess safety and tolerability of Fulvestrant administration in each tumor<br /><br>type group<br /><br>• To assess quality of life (QoL) and symptoms in each tumor type group</p><br>