Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

Endometrial Carcinoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334295
• Other study ID #: 9238GR/0002
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2006
• Last updated: June 11, 2012
• Start date: December 2002
• Est. completion date: January 2011

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Carcinoma
• Endometrial Neoplasms

Intervention

Drug:
• Fulvestrant
A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.

Locations

Country	Name	City	State
Germany	Research Site	Erlangen
Germany	Research Site	Göttingen
Germany	Research Site	Halle
Germany	Research Site	Jena
Germany	Research Site	Lübeck
Germany	Research Site	Mainz
Germany	Research Site	Münster
Germany	Research Site	Neunkirchen
Germany	Research Site	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 1 year	No
Secondary	Time to Progression of Disease (TTP-Time To Progression, for ITT Set)	median TTP	ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)	No
Secondary	Determination (for ITT Set): Median Survival	median overall survival (OS)	ICF to the date of death	No
Secondary	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	ICF to Last Patient Out (LPO)	Yes
Secondary	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).	ICF (Baseline) up to 12 months (12 visits)	No