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OpenTrials
Completed

NCT Number: NCT00334295

Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

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.

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Key information

Conditions

Endometrial Carcinoma Disease Attributes Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Erlangen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fulvestrant

Drug

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

Primary outcomes

  1. 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

    Time frame: up to 1 year

    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 outcomes

  1. Time to Progression of Disease (TTP-Time To Progression, for ITT Set)

    Time frame: ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)

    median TTP

  2. Determination (for ITT Set): Median Survival

    Time frame: ICF to the date of death

    median overall survival (OS)

  3. Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities

    Time frame: ICF to Last Patient Out (LPO)

    number of adverse events

  4. Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)

    Time frame: ICF (Baseline) up to 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2006
Registry last updated
Jul 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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