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Active Not Recruiting NCT01068249

Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer

Conditions: Endometrial Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 42
Sponsor: M.D. Anderson Cancer Center

Location: Morristown Memorial Hospital, Women's Cancer Center Morristown New Jersey

Summary

The goal of this clinical research study is to learn if the combination of RAD001 (everolimus) and Femara (letrozole) can help to control recurrent or progressive endometrial cancer. The safety of this drug combination will also be studied.

Eligibility Criteria

Inclusion Criteria: 1. Patients must have signed an approved informed consent. 2. Histologically confirmed endometrial cancer (endometrioid, serous, or clear cell, or mixed histology; any grade) which is considered progressive or recurrent. 3. Patients may have failed no more than two prior chemotherapeutic regimens for recurrent or advanced disease (including adjuvant therapy). Chemotherapy administered in conjunction with radiation as a radio-sensitizer is not counted as a prior treatment for recurrent or advanced disease. 4. All patients must have measurable disease as defined by RECIST 1.1. 5. Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST. Tumors within a previously irradiated field will be designated as "non-target" lesions, unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy. 6. Patients must have a Zubrod performance status of 0, 1, or 2. 7. Patients must not be of child bearing potential. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal for greater than 12 months. Patients in whom ovaries are present and were not previously menopausal at the time of hysterectomy, should have a serum estradiol \< 10 pg/mL to confirm ovarian senescence. 8. Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of \>1,500/Fl, a hemoglobin level of \>/=9gm/dL and a platelet count of \>100,000/Fl. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines. 9. Patients must have an adequate renal function of \>50cc/min as documented by the Cockcroft Gault creatinine clearance formula: Estimated GFR = (140 - age) x (weight kg) divided by 72 x serum Creatinine (non-IDMS) x 0.85 (female) 10. Patients must have adequate hepatic function as documented by a serum bilirubin \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT01068249). StuddyBuddy aggregates publicly available trial information.