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

NCT00171808 | Completed Phase 2

• 2 other identifiers: CFEM345ADE08EudraCT-Number: 2004-003886-34
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 15

Brief 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. This trial will investigate the efficacy and safety of letrozole in the treatment of advanced or recurrent hormone receptor-positive endometrial cancer .

Conditions

Endometrial Cancer

Keywords

Endometrial Cancer; Aromatase inhibitor; Advanced or recurrent; hormone receptor positive

Outcome Measures

Primary Outcomes (1)

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

  until disease progression

Secondary Outcomes (2)

• Time to progression (TTP)

  until disease progression

• Overall survival (OS)

  until disease progression

Study Arms (1)

Letrozole

EXPERIMENTAL

Drug: Letrozole

Interventions

Letrozole DRUG

Letrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

Ebersberg, Germany

Celle, Germany

Location

Heidelberg, Germany

Ebersberg, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, Germany

Location

Ebersberg, Germany

Hamburg, Germany

Location

Novartis Investigative Site

Hamburg, Germany

Location

Celle, Germany

Hanover, Germany

Location

Tuebingen, Germany

Heidelberg, Germany

Location

Novartis Investigative Site

Karlsruhe, Germany

Location

Muenchen, Germany

Kiel, Germany

Location

Muenchen, Germany

München, Germany

Location

Novartis Investigative Site

München, Germany

Location

Novartis Investigative Site

Oberaudorf, Germany

Location

Novartis Investigative Site

Rostock, Germany

Location

Novartis Investigative Site

Tübingen, Germany

Location

Hannover, Germany

Wolfsburg, Germany

Location

Related Links

• Abstract Page 39 (ISSN 1048891X)

MeSH Terms

Conditions

Endometrial Neoplasms; Recurrence

Interventions

Letrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: April 1, 2005
• Primary Completion: May 1, 2010
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

DE (15)