Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00334295
• Collaborator: (none)
• Enrollment: 35
• Locations: 9
• Duration (Months): 97
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Carcinoma	Drug: Fulvestrant	Phase 2

Study Design

• Study Type: Interventional
• 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: Dec 1, 2002
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Outcome Measures

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 [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) [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 [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 [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) [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Erlangen		Germany
2	Research Site	Göttingen		Germany
3	Research Site	Halle		Germany
4	Research Site	Jena		Germany
5	Research Site	Lübeck		Germany
6	Research Site	Mainz		Germany
7	Research Site	Münster		Germany
8	Research Site	Neunkirchen		Germany
9	Research Site	Rostock		Germany

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: AstraZeneca Germany Medical Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00334295
• Other Study ID Numbers: 9238GR/0002
• First Posted: Jun 7, 2006
• Last Update Posted: Jul 31, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by AstraZeneca: Recurrent or metastatic endometrial carcinoma
• Additional relevant MeSH terms: Carcinoma; Endometrial Neoplasms; Fulvestrant

Study Results

Participant Flow

Arm/Group Title	Fulvestrant
Arm/Group Description	A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Period Title: Overall Study
STARTED	35
COMPLETED	30
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Fulvestrant
Arm/Group Description	A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Overall Participants	35
Age, Customized (years) [Median (Full Range) ]
Median (Full Range) [years]	69.5
Sex: Female, Male (Count of Participants)
Female	35 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fulvestrant
Arm/Group Description	A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Measure Participants	26
Number [participants]	5 14.3%

2. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fulvestrant
Arm/Group Description	A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Measure Participants	26
Median (95% Confidence Interval) [months]	3.1

3. Secondary Outcome

Title	Determination (for ITT Set): Median Survival
Description	median overall survival (OS)
Time Frame	ICF to the date of death

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fulvestrant
Arm/Group Description	A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Measure Participants	26
Median (95% Confidence Interval) [months]	16.7

4. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fulvestrant
Arm/Group Description	A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Measure Participants	35
Number [adverse events]	169

5. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

FACT-En was evaluated descriptively for change from baseline of the total score using the AST population, presented for the first 12 visits. Due to death or other patients individual reasons only 4 participants were motivated to complete the FACT-En questionnaire form.

Arm/Group Title	Fulvestrant
Arm/Group Description	A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Measure Participants	4
Mean (95% Confidence Interval) [units on a scale]	6.0 (1.3-)

Adverse Events

Arm/Group Title	Fulvestrant
Arm/Group Description	A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
All Cause Mortality
	Fulvestrant
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fulvestrant
	Affected / at Risk (%)	# Events
Total	11/ (NaN)
Cardiac disorders
Tachycardia	1/35 (2.9%)
Gastrointestinal disorders
Ileus	2/35 (5.7%)
Abdominal pain	1/35 (2.9%)
Vomiting	1/35 (2.9%)
Subileus	1/35 (2.9%)
General disorders
General physical health deterioration	1/35 (2.9%)
Oedema peripheral	1/35 (2.9%)
Infections and infestations
Gastroenteritis	1/35 (2.9%)
Wound infection	1/35 (2.9%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/35 (2.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant	1/35 (2.9%)
Nervous system disorders
Paresis	1/35 (2.9%)
Psychiatric disorders
Depression	1/35 (2.9%)
Renal and urinary disorders
Renal failure	1/35 (2.9%)
Respiratory, thoracic and mediastinal disorders
Dyspnoe	1/35 (2.9%)
Pleural effusion	1/35 (2.9%)
Aspiration	1/35 (2.9%)
Vascular disorders
Hypertension	1/35 (2.9%)
Pulmonary embolism	1/35 (2.9%)
Vaginal haemorrhage	1/35 (2.9%)
Deep vein thrombosis	1/35 (2.9%)
Other (Not Including Serious) Adverse Events
	Fulvestrant
	Affected / at Risk (%)	# Events
Total	32/ (NaN)
Ear and labyrinth disorders
Vertigo	2/35 (5.7%)
Gastrointestinal disorders
Abdominal pain	4/35 (11.4%)
Ascites	3/35 (8.6%)
Constipation	4/35 (11.4%)
Diarrhoea	4/35 (11.4%)
Flatulence	2/35 (5.7%)
Nausea	9/35 (25.7%)
Vomiting	4/35 (11.4%)
General disorders
Asthenia	2/35 (5.7%)
Fatigue	8/35 (22.9%)
Oedema peripheral	3/35 (8.6%)
Infections and infestations
Nasopharyngitis	2/35 (5.7%)
Urinary tract infection	7/35 (20%)
Injury, poisoning and procedural complications
Procedural site reaction	2/35 (5.7%)
Metabolism and nutrition disorders
Anorexia	2/35 (5.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/35 (8.6%)
Back pain	2/35 (5.7%)
Bone pain	3/35 (8.6%)
Pain in extremity	2/35 (5.7%)
Nervous system disorders
Headache	2/35 (5.7%)
Psychiatric disorders
Insomnia	2/35 (5.7%)
Reproductive system and breast disorders
Vaginal haemorrhage	4/35 (11.4%)
Respiratory, thoracic and mediastinal disorders
Cough	2/35 (5.7%)
Dyspnoea	6/35 (17.1%)
Skin and subcutaneous tissue disorders
Erythema	2/35 (5.7%)
Vascular disorders
Hot flush	6/35 (17.1%)
Lymphoedema	2/35 (5.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.