Back to resultsFulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.
Primary Purpose
Endometrial Carcinoma
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Fulvestrant
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Carcinoma focused on measuring Recurrent or metastatic endometrial carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, recurrent or metastatic endometrial carcinoma Postmenopausal Hormonreceptor positive Exclusion Criteria: Pre-treatment with Fulvestrant Previous endocrine therapy of the endometrial carcinoma Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin
Sites / Locations
- Research Site
- Research Site
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Outcomes
Primary Outcome Measures
Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant
Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.
Secondary Outcome Measures
Time to Progression of Disease (TTP-Time To Progression, for ITT Set)
median TTP
Determination (for ITT Set): Median Survival
median overall survival (OS)
Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities
number of adverse events
Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)
Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00334295
Brief Title
Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.
Official Title
An Open, Non-randomised Multicentre Phase II Study to Assess the Efficacy and Tolerability of a 250 mg Monthly Dose of i.m. Applied Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy of a monthly administration of Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of the clinical tumour response after 3 injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Carcinoma
Keywords
Recurrent or metastatic endometrial carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Primary Outcome Measure Information:
Title
Determination (for ITT (Intet-to-Treat Set): Efficacy of a Monthly Administration of Fulvestrant in Patients With Recurrent or Metastatic Endometrial Carcinoma by Assessment of the Clinical Tumour Response After 3 Injections of Fulvestrant
Description
Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Time to Progression of Disease (TTP-Time To Progression, for ITT Set)
Description
median TTP
Time Frame
ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)
Title
Determination (for ITT Set): Median Survival
Description
median overall survival (OS)
Time Frame
ICF to the date of death
Title
Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities
Description
number of adverse events
Time Frame
ICF to Last Patient Out (LPO)
Title
Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)
Description
Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0 to 100 (0 = worst level of well-being; 100 = highest level of well-being).
Time Frame
ICF (Baseline) up to 12 months (12 visits)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed, recurrent or metastatic endometrial carcinoma
Postmenopausal
Hormonreceptor positive
Exclusion Criteria:
Pre-treatment with Fulvestrant
Previous endocrine therapy of the endometrial carcinoma
Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Germany Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Erlangen
Country
Germany
Facility Name
Research Site
City
Göttingen
Country
Germany
Facility Name
Research Site
City
Halle
Country
Germany
Facility Name
Research Site
City
Jena
Country
Germany
Facility Name
Research Site
City
Lübeck
Country
Germany
Facility Name
Research Site
City
Mainz
Country
Germany
Facility Name
Research Site
City
Münster
Country
Germany
Facility Name
Research Site
City
Neunkirchen
Country
Germany
Facility Name
Research Site
City
Rostock
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.
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