Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma

NCT00414076 | Terminated Phase 2 Results DMC

• 2 other identifiers: 2006-0453NCI-2010-00554
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is learn if taking Femara (letrozole) after a hysterectomy (surgical removal of the uterus) for uterine leiomyosarcoma will delay or prevent the cancer from coming back.

Conditions

Leiomyosarcoma; Uterine Neoplasm

Keywords

Uterine Leiomyosarcoma; Uterine Neoplasm; Uterine Sarcomas; Uterine Cancer; Uterus; LMS; ER Positivity; Femara; Letrozole

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Number of participants progressed or death from study entry.

  Every 12 weeks

Study Arms (2)

Letrozole

ACTIVE COMPARATOR

Letrozole 2.5 mg Tablet By Mouth Daily for 12 Weeks.

Drug: Letrozole

Standard of Care

NO INTERVENTION

Patients receive no treatment. Follow up every 3 months.

Interventions

Letrozole DRUG

2.5 mg Tablet By Mouth Daily for 12 Weeks.

Also known as: Femara

Letrozole

Eligibility Criteria

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

You may qualify if:

• Patients must have signed an approved informed consent.
• Histologically confirmed uterine leiomyosarcoma with disease limited to the uterus (determined by surgical staging or radiologic imaging).
• Tumors must express ER positivity by immunohistochemistry (ER expression \>10% by immunohistochemistry).
• Patients must have a hysterectomy and bilateral oophorectomy prior to initiation of therapy.
• All patients must have no measurable disease. Measurable disease is defined as lesions that can be measured by physical examination or by means of imaging techniques. Imaging must be done within 6 weeks of study entry.
• Patients must have a Zubrod performance status of 0, 1, or 2.
• Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of greater than 1,000/Fl, a hemoglobin level of greater than or equal to 9.0 gm/dL and a platelet count of greater than 75,000/dL.
• Patients must have an adequate renal function as documented by serum creatinine less than or equal to 2.0 mg/dL.
• Patients must have adequate hepatic function as documented by a serum bilirubin less than or equal to 2.5 mg/dL.
• Aspartate transaminase (SGOT) must be less than 3x institutional upper limit of normal.
• Patients must have recovered from the effects of prior surgery.
• No more than 12 weeks must have elapsed from hysterectomy.
• Patients must be 18 years or older.

You may not qualify if:

• Patients who do not have pure uterine sarcomas (i.e., no mixed malignant Mullerian tumors).
• Patients with any other severe concurrent disease, which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases.
• Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.
• Patients who were taking or have a history of taking letrozole or another aromatase inhibitor.
• Patients with active or uncontrolled systemic infection.
• Patients with history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with an ejection fraction under 40%.
• Patients who are pregnant or breast-feeding.
• Presence of clinically apparent untreated central nervous system metastases.
• Presence of carcinomatous meningitis.
• Patients currently receiving chemotherapy or radiation therapy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leiomyosarcoma; Uterine Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Coleman,Robert,M.D. / Gyn Onc & Reproductive Medicine
• Organization: UT MD Anderson Cancer Center

RColeman@mdanderson.org

7137923203

Study Officials

• Robert Coleman, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Study Start: December 19, 2006
• Primary Completion: July 13, 2017
• Study Completion: July 13, 2017
• Last Updated: November 20, 2018
• Results First Posted: October 11, 2018

Record last verified: 2018-10

Locations

US (1)