Letrozole in Patients With Ovarian Tumors
- 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.
|Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer||Drug: Letrozole||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Letrozole in Patients With Recurrent Advanced Borderline Tumors or Low Grade Epithelial Cancers of the Ovary, Fallopian Tube and Primary Peritoneum|
- Objective Response Rate Following Treatment With Letrozole [ Time Frame: 2 month intervals for first 2 years ]Using RECIST criteria, Objective Response evaluated every 2 months.
|Study Start Date:||September 2003|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
2.5 mg by mouth (PO) daily
2.5 mg PO Once Daily
Other Name: Femara
Letrozole is an anticancer hormone that is FDA approved for use in patients with advanced breast cancer.
Before you can be enrolled in this study, you must go through some screening tests to make sure you are eligible. The screening tests include a complete medical history and physical exam, including measurement of your pulse rate, breathing rate, temperature, height, weight, and blood pressure. The physical examination will also include measurement of any visible cancer lesions. You will be asked what medications you are taking, including over the counter medications, herbal medications, and vitamins. You will have chest x-rays and/or CT or MRI scans to measure the size of your tumors. You will have routine blood tests (about 2 and a 1/2 tablespoons) performed.
If you qualify for the study, you will take Letrozole once a day by mouth. Letrozole will be dispensed in the form of a tablet. Four to eight weeks worth of Letrozole will be prescribed to you by your treatment doctor at each visit. You will continue to receive Letrozole as long as you are responding to treatment.
You will be required to come back for check-up at least once every 2 months while on study for the first two years. You should contact the study doctor if you feel unwell or feel the need to see the doctor before your appointment earlier than your designated appointment.
At each follow-up visit, you will have a complete physical exam. The chest x-rays and/or CT or MRI scans will be repeated every 2 months, and at the time you complete the trial, or at any other time if necessary. Blood tests (about 1 tablespoon) will be performed every 2 months. Information about the medications you are taking, or medical problems you have had since your last visit will be collected. At each follow-up visit, you will also be asked to complete a one page, paper and pencil check off sheet. You will be asked to identify symptoms you may be having and to note the amount of distress each symptom is causing you.
You will be taken off study if the disease gets worse or intolerable side effects occur and your doctor will discuss possible treatment options with you.
However, as long as you continue to benefit from Letrozole treatment, you will continue on this treatment. If you are on letrozole treatment beyond two years, you will be followed up at three months interval. At these follow up visits, you will be asked questions about your medical history and have a physical exam. You will also have blood (about tablespoon) and urine tests, and/or radiological evaluation of the tumor. As long as you continue to benefit from letrozole treatment, you will be followed up.
Your status will be followed for as long as possible even after you are taken off the study drug. You will be contacted by phone or asked to come to the clinic for a routine visit. You will be contacted every 6 weeks for 1 year after the study and every 12 weeks for the rest of your life.
This is an investigational study. Letrozole is not approved by the FDA for the treatment of recurrent low grade or borderline ovarian, fallopian tube or primary peritoneal cancer. A total of up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505661
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||John J. Kavanagh, MD||M.D. Anderson Cancer Center|