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Endometrial CancerPhase 2deFENDNCT00171808

Letrozole in the Treatment of Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer

A Phase 2 study testing Letrozole in people with Endometrial Cancer, run by Novartis Pharmaceuticals at 15 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In Western industrialized countries, endometrial cancer is the most common malignancy of the female reproductive tract. The general therapy options are surgery, radiotherapy, chemotherapy and endocrine therapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Letrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
15 sitesGermany
Study dates
Apr 2005to May 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age > 18 years
  • Presence of histologically proven adenocarcinoma or adenosquamous carcinoma of the endometrium
  • Presence of advanced or recurrent endometrial cancer, FIGO stage I-IV, incurable with surgery and/or radiation therapy
  • Documented ER and/or PgR positive endometrial cancer. Hormone receptor positivity is defined according to routine practice at each participating laboratory.
  • Patient must be postmenopausal defined as
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  • Age ≥55 years.
  • Age <55 but no spontaneous menses for at least 1 year.
  • Age <55 and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy), and with postmenopausal gonadotrophin levels (luteinizing hormone and follicle stimulating hormone levels >40 IU/L) or postmenopausal estradiol levels (<5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved.
  • Bilateral oophorectomy
  • Radiation menopause
  • Presence of measurable disease (by clinical/radiological examination - according to RECIST criteria : minimum indicator lesion size : 20 mm (unless spiral CT scan in which case > 10 mm)
  • ECOG performance status of 0, 1 or 2
  • Adequate bone marrow function (WBC ≥ 3.5 x 1'000'000'000/L and platelets ≥ 100.0 x 1'000'000'000/L) and hemoglobin > 10.0 g/dl
  • Adequate renal function (creatinine < 120 µmol/L) and hepatic function (bilirubin < 25 µmol/L, AST (SGOT < 60 U/L)
  • Minimum life expectancy of at least 6 months
  • Patients who are accessible for treatment and follow-up

Who cannot join

  • Presence of non-measurable disease only
  • Other concomitant anti-cancer treatment (except external radiation treatment [XRT] for symptomatic metastatic lesions if other assessable untreated lesions are present)
  • Prior treatment with aromatase inhibitors or anti-estrogens (up to one previous progestational hormone therapy regimen for recurrent disease is permitted)
  • Clear cell or papillary serous histology, uterine sarcomas, mixed Mullerian tumors (MMT) and/or adenosarcomas
  • Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin's disease or non-Hodgkin lymphoma (NHL), provided 5 years have elapsed from completion of therapy, and there has been no recurrence
  • Known central nervous system (CNS) metastases, bilateral diffuse lymphangiosis carcinoma of the lung (>50 % of lung involvement, or dyspnea at rest requiring supplemental oxygen therapy), evidence of metastases estimated as more than a third of the liver as defined by sonogram and/or CT scan
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  • Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's Syndrome, Addison's disease (treated or untreated)
  • Unstable angina and uncontrolled cardiac disease
  • Treatment with other investigational drugs (drugs not marketed for any indication) within the past 30 days and/or the concomitant use of investigational drugs
  • A history of non-compliance to medical regimens and patients who, in the opinion of the investigator, are unlikely to cooperate fully during the study
  • Inability to swallow pills
  • Additional protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Germany15 sites

  • Ebersberg, Germany

    Celle

  • Heidelberg, Germany

    Ebersberg

  • Novartis Investigative Site

    Freiburg im Breisgau

  • Ebersberg, Germany

    Hamburg

  • Novartis Investigative Site

    Hamburg

  • Celle, Germany

    Hanover

  • Tuebingen, Germany

    Heidelberg

  • Novartis Investigative Site

    Karlsruhe

  • Muenchen, Germany

    Kiel

  • Muenchen, Germany

    München

  • Novartis Investigative Site

    München

  • Novartis Investigative Site

    Oberaudorf

  • Novartis Investigative Site

    Rostock

  • Novartis Investigative Site

    Tübingen

  • Hannover, Germany

    Wolfsburg

Other trials in Germany

About this study

Official title: Phase II Study on Letrozole in Patients With Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer

In Western industrialized countries, endometrial cancer is the most common malignancy of the female reproductive tract.

The general therapy options are surgery, radiotherapy, chemotherapy and endocrine therapy. This trial will investigate the efficacy and safety of letrozole in the treatment of advanced or recurrent hormone receptor-positive endometrial cancer .

Being tested
Letrozole
Keywords
Endometrial Cancer, Aromatase inhibitor, Advanced or recurrent, hormone receptor positive
Medical subject headings
Endometrial Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00171808
Study groupRoleWhat they receive
LetrozoleExperimentalNot described
Receives: Drug: Letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical response rate (partial response PR and complete response CR) according to RECIST at least once during the treatment period

    Measured: until disease progression

Secondary outcomes (2)

  1. Time to progression (TTP)

    Measured: until disease progression

  2. Overall survival (OS)

    Measured: until disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00171808
Sponsor's protocol ID
CFEM345ADE08
Other IDs
EudraCT-Number: 2004-003886-34
Acronym
deFEND
Status last verified
Nov 2016
First submitted
13 Sep 2005
Last updated
18 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Letrozole in people with Endometrial Cancer, run by Novartis Pharmaceuticals at 15 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical response rate (partial response PR and complete response CR) according to RECIST at least once during the treatment period (time frame: until disease progression). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00171808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.

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deFEND Clinical Trial NCT00171808 | AzTrials