Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Novartis
Information provided by (Responsible Party):
Suzanne George, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00856050
First received: March 4, 2009
Last updated: April 24, 2014
Last verified: February 2014
  Purpose

The purpose of this research study is to determine if letrozole is effective at controlling the growth or spread of estrogen and/or progesterone receptor positive uterine leiomyosarcoma. This drug has been used in research studies for other cancers and is currently approved by the FDA for use in breast cancer. Because letrozole lowers hormone levels in the body, it may be helpful to control tumors that express hormone receptors ( ER/PR).


Condition Intervention Phase
Leiomyosarcoma
Drug: letrozole
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Clinical Study of Letrozole in Women With Advanced Estrogen/Progesterone Receptor Positive Uterine Leiomyosarcoma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Evaluate the Activity of Letrozole in Post Menopausal Women With Advanced Estrogen (ER)/Progesterone (PR)-Positive Uterine Leiomyosarcoma. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The progression free survival rate at 12 weeks was 46% (90%CI, 29%-64%)


Enrollment: 27
Study Start Date: February 2009
Study Completion Date: March 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: letrozole
single arm trial - all patients received letrozole 2.5mg by mouth per day
Drug: letrozole
Taken orally once a day continuously
Other Name: Femara

Detailed Description:
  • Participants will take letrozole orally once a day. During the research study the following tests and procedures will be performed:
  • Visit 1 (Day 1): physical examination, vital signs and blood work
  • Visit 2 (Day 43): physical examination, vital signs, blood work, CT or MRI scan
  • Visit 3 (Day 85): physical examination, vital signs, blood work, CT or MRI scan
  • Participants will remain on the study drug as long as they do not have any serious sife effect and their disease does not get worse
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed, advanced estrogen (ER)/progesterone receptor (PR) positive leiomyosarcoma of uterine origin, for which standard multi-modality curative therapies do not exist or are no longer effective
  • Patients must be postmenopausal. Postmenopausal is defined as any of the following: 1)Bilateral oophorectomy 2) 60 years of age or older 3)Younger than 60 AND amenorrheic for 12 months or more AND follicle stimulating hormone (FSH) and estradiol (E2) within postmenopausal range 4)Ovarian ablation radiotherapy confirmed by FSH and estradiol (E2) level in the postmenopausal range
  • Evidence of ER and/or PR positivity, either in primary or secondary tumor tissue
  • Measurable disease outside of a prior irradiated area as defined by RECIST guidelines. A lesion in a previously irradiated area is not eligible for measurable diseae unless there is objective evidence of progression of the lesion prior to study enrollment
  • 18 years of age or older
  • Life expectancy of 3 months or more
  • ECOG Performance Status 0, 1, or 2
  • No limit to number of prior chemotherapies or biologics
  • Normal organ function as outlined in the protocol
  • Resolution of clinically significant toxicities related to prior therapies

Exclusion Criteria:

  • Pre-menopausal women
  • Participants who have had systemic anti-cancer therapy within 3 weeks of study entry (8 weeks for nitrosoureas or mitomycin C)
  • Palliative radiotherapy within 2 weeks of study entry
  • Major surgery within 2 weeks of study entry
  • Prior hormonal therapy for the treatment of uterine leiomyosarcoma (prior hormone replacement therapy is allowed)
  • Participants may not be receiving any other concomitant investigational agents
  • Uncontrolled brain or central nervous system metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Individuals with a history of a different malignancy, other than cervical cancer in situ, basal cell or squamous cell carcinoma of the skin, are ineligible, except if they have been disease-free for at least 5 years, and are deemed by the investigator to be at low risk for recurrence of that malignancy OR other primary malignancy is neither currently clinically significant nor requiring active intervention
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856050

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Novartis
Investigators
Principal Investigator: Suzanne George, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Suzanne George, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00856050     History of Changes
Other Study ID Numbers: 08-341
Study First Received: March 4, 2009
Results First Received: January 9, 2014
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
estrogen receptor positive
progesterone receptor positive
letrozole

Additional relevant MeSH terms:
Leiomyosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Letrozole
Progesterone
Estrogens
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014