Letrozole in Patients With Ovarian Tumors
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Fallopian Tube Neoplasms
Intervention: Letrozole
Intervention description: 2.5 mg PO Once Daily
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer; Letrozole; Femara

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 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.

          3. The ovarian tumors have to be either estrogen receptor or progesterone receptor
             positive.

          4. Measurable disease by radiological imaging studies. Raised CA125 tumor marker alone
             and lesions located in previously irradiated areas are not considered measurable.

          5. Age greater than 18 years of age.

          6. Expected survival of more than 12 weeks.

          7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

          8. Willingness to comply with study procedures and follow up examinations.

          9. 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).

         10. 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.

         11. Have adequate bone marrow reserve as indicated by absolute neutrophil count (ANC)>
             1,500/ mm3; platelet count > 100,000/mm3; hemoglobin > 9.0g/dL.

         12. 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.

         13. Have adequate renal function tests as indicated by serum creatinine of < 1.5mg/dl.

        Exclusion Criteria:

          1. Failure to recover from any prior surgery or major surgery within 4 weeks of study
             entry

          2. Patients with sarcomatous, germ cell or stromal elements in their cancers are not
             eligible.

          3. 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.

          4. Pregnant or lactating women

          5. Leptomeningeal or carcinomatous meningitis

          6. Unstable medical conditions such as uncontrolled cardiac arrythmia or history of
             myocardial infarction within 6 months

          7. Any severe, concurrent disease, infection or co-morbidity that, in the judgment of the
             investigator, would make the patient inappropriate for study entry.

          8. Any signs of intestinal obstruction interfering with nutrition

          9. 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.

         10. Patients with more than 4 prior chemotherapy regimes with all platinum regimes counted
             as one.

         11. 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.

         12. Patients on estrogen and progesterone replacement therapy must have a wash out period
             of 4 weeks.

         13. 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

         14. Patients receiving concurrent chemotherapy, radiotherapy or immunotherapy.

         15. Participation in any investigational drug study within 30 days of the first day of
             dosing.

         16. Psychiatric disorders that would preclude obtaining informed consent and participation
             in an ongoing research study

         17. Patients with a known history of human immunodeficiency virus (HIV) infection

         18. Patients with inadequately treated serious thromboembolic disease such as pulmonary
             embolism and deep vein thrombosis, or with known clotting disorders.