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Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

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ClinicalTrials.gov Identifier: NCT00334295
Recruitment Status : Completed
First Posted : June 7, 2006
Results First Posted : July 31, 2012
Last Update Posted : July 31, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Endometrial Carcinoma Drug: Fulvestrant Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2002
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Fulvestrant


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


Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334295


Locations
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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, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Germany Medical Director, MD AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00334295     History of Changes
Other Study ID Numbers: 9238GR/0002
First Posted: June 7, 2006    Key Record Dates
Results First Posted: July 31, 2012
Last Update Posted: July 31, 2012
Last Verified: June 2012

Keywords provided by AstraZeneca:
Recurrent or metastatic endometrial carcinoma

Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs