Evaluate the efficacy of the ER-antagonist Fulvestrant in women with estrogen receptor positive (ER+) low grade gynecological cancers
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the response rate (RR) upon Fulvestrant treatment, comprising
either partial or complete response, as determined by RECIST v1.1 criteria, in
each tumor type group
Secondary outcome
• To determine progression-free survival (PFS) upon Fulvestrant treatment,
after 3 years, in each tumor type group
• To assess duration of response in each tumor type group
• To assess safety and tolerability of Fulvestrant administration in each tumor
type group
• To assess quality of life (QoL) and symptoms in each tumor type group
Background summary
Many gynecological malignancies are characterized by estrogen receptor (ER)
expression, including low grade uterine sarcomas (LG-US), low grade endometrial
carcinomas (LG-EC), sex cord stromal tumors and low grade epithelial serous
ovarian cancers (LG-SC). Although several reports suggest that endocrine
therapy can be effective in such gynecological cancers, because of their rare
nature, there is still no consensus reached on the criteria needed to clearly
define which population of patients would specifically benefit from anti-ER
treatment
Study objective
Evaluate the efficacy of the ER-antagonist Fulvestrant in women with estrogen
receptor positive (ER+) low grade gynecological cancers
Study design
Single arm, prospective, multi-center, tandem two-stage designed phase II
study, grouped by tumor type
Intervention
Fulvestrant intramuscular injection (2x 250mg), once every 2 weeks for the
first month, and then monthly until completion of the study
Study burden and risks
The hypothesis is that Fulvestrant will show clinical efficacy in these
patients with low-grade gynecological tumors that are resistant to other
hormonal therapies and thus constitutes a new option for these patients before
moving to cytotoxic therapy. The risks for the patient are drug-related side
effects, but in general the safety profile of Fulvestrant is favorable. Weighed
against the possible advantage of having a clinical response, the risk-benefit
analysis according to the investigators is positive.
Herestraat 49
Leuven 3000
BE
Herestraat 49
Leuven 3000
BE
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
• 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-005018-76-NL |
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL65737.031.18 |