Letrozole in Patients With Ovarian Tumors

NCT00505661 | Terminated Phase 2 Results

• 1 other identifier: 2003-0486
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

• To determine the objective response rate of Letrozole when administered to patients with advanced or recurrent borderline tumors or low-grade epithelial cancers from the ovary , fallopian tube or peritoneum.
• To determine the time to tumor progression of patients with advanced or recurrent borderline tumors or low-grade epithelial cancers from the ovary, fallopian tube or peritoneum.
• To identify the biological markers to predict response to Letrozole and study the aspects of the hormones in these types of tumors.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer; Letrozole; Femara

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate Following Treatment With Letrozole

  Using RECIST criteria, Objective Response evaluated every 2 months.

  2 month intervals for first 2 years

Study Arms (1)

Letrozole

EXPERIMENTAL

2.5 mg by mouth (PO) daily

Drug: Letrozole

Interventions

Letrozole DRUG

2.5 mg PO Once Daily

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:

• History of histologically confirmed diagnosis of borderline tumors or low-grade epithelial cancer from the ovary, fallopian tube or primary peritoneum. Eligible histologies include borderline serous papillary, borderline mucinous papillary, borderline endometrioid, low-grade serous papillary, low-grade mucinous papillary, low-grade endometrioid and mixture of the above. Patients whose tumors are histologically borderline but have low grade invasive implants are also included. Patients whose tumors are histologically borderline but which include high grade components are excluded.
• Recurrent or advanced borderline or low-grade epithelial ovarian, fallopian tube or primary peritoneal tumors not amenable to surgery, or patients who have measurable residual disease at the end of secondary cytoreduction.
• The ovarian tumors have to be either estrogen receptor or progesterone receptor positive.
• Measurable disease by radiological imaging studies. Raised CA125 tumor marker alone and lesions located in previously irradiated areas are not considered measurable.
• Age greater than 18 years of age.
• Expected survival of more than 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Willingness to comply with study procedures and follow up examinations.
• Have written informed consent. (Signature on consent form indicating that the patient is aware of the nature of her disease and willingly gives written consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternative treatment options and potential benefits and risks associated with the therapy).
• Known history of Central nervous system metastases allowed if patients have had treatment, are neurologically stable, and do not require oral or intravenous steroids or anti-convulsants, provided brain scan (Computer Assisted Tomography or Magnetic Resonance Imaging Scans) shows absence of active disease.
• Have adequate bone marrow reserve as indicated by absolute neutrophil count (ANC)\> 1,500/ mm3; platelet count \> 100,000/mm3; hemoglobin \> 9.0g/dL.
• Have adequate liver function tests as indicated by bilirubin \< 1.5 X normal, alanine amino-transferase (ALT)\< 3 X normal; and aspartate amino-transferase (AST) \< 3 X normal.
• Have adequate renal function tests as indicated by serum creatinine of \< 1.5mg/dl.

You may not qualify if:

• Failure to recover from any prior surgery or major surgery within 4 weeks of study entry
• Patients with sarcomatous, germ cell or stromal elements in their cancers are not eligible.
• Patients with intermediate and high-grade primary ovarian, fallopian tube, and primary peritoneal epithelial carcinoma. Patients whose tumors are histologically borderline but which includes high grade components are excluded.
• Pregnant or lactating women
• Leptomeningeal or carcinomatous meningitis
• Unstable medical conditions such as uncontrolled cardiac arrythmia or history of myocardial infarction within 6 months
• Any severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for study entry.
• Any signs of intestinal obstruction interfering with nutrition
• Treatment with chemotherapy, radiotherapy, radiopharmaceuticals or immunotherapy within 4 weeks of first study dosing with letrozole (within 6 weeks for nitrosureas or mitomycin C) or failure to recover from the toxic effects of any of these therapies prior to study entry.
• Patients with more than 4 prior chemotherapy regimes with all platinum regimes counted as one.
• Patients who has had prior anti-cancer hormonal therapy for ovarian cancer with aromatase inhibitors. Patients treated with gonadotrophin agonist, gonadotropin antagonist and Selective estrogen receptor modulators (SERMS) are allowed. Patients on hormone replacement therapy or who have had fertility treatment with estrogens and gonadotropins are also allowed.
• Patients on estrogen and progesterone replacement therapy must have a wash out period of 4 weeks.
• A history of prior malignancy except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has not been disease- free for at least five years
• Patients receiving concurrent chemotherapy, radiotherapy or immunotherapy.
• Participation in any investigational drug study within 30 days of the first day of dosing.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John Kavanagh, MD / Professor
• Organization: UT MD Anderson Cancer Center

713-792-2933

Study Officials

• John J. Kavanagh, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 23, 2007
• Study Start: September 1, 2003
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 18, 2012
• Results First Posted: October 19, 2010

Record last verified: 2012-04

Locations

US (1)