A Phase II Study of RAD001 in Patients With Recurrent Endometrial Cancer

Fecha de inicio: 1 de junio de 2004

Inclusion Criteria: 1. Histologically confirmed progressive or recurrent endometrial cancer (endometrioid or mixed with endometrioid component histology; any grade). 2. Patients may have failed no more than two prior chemotherapies for the recurrent disease (does not include chemosensitizing radiation). 3. All patients must have measurable disease. Measurable disease is defined as lesions that can be measured by physical examination or by means of imaging techniques. Ascites and pleural effusions are not considered measurable disease. 4. Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils + bands) of \>/=1,500/Fl, a hemoglobin level of \>/=9.0 gm/dL and a platelet count of \>/=100,000/Fl. 5. Patients must have an adequate renal function as documented by serum creatinine \</=2.0 mg/dL. 6. Patients must have adequate hepatic function as documented by a serum bilirubin \</=1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor. Aspartate transaminase (SGOT) must be \</=3x institutional upper limit of normal unless the liver is involved with tumor, in that case the aspartate transaminase must be \</=5x institutional upper limit of normal. 7. Patients must have a Zubrod performance status of 0, 1, or 2. 8. Patients must have signed an approved informed consent. Exclusion Criteria: 1. Patients who have previously received RAD001 or another mammalian target of rapamycin (mTOR) inhibitor. 2. Patients whose tumors have serous carcinomas, mixed malignant mullerian tumors (MMMT) components or uterine sarcomas. 3. Patients who have isolated recurrences (vaginal, pelvic, or para-aortic) that are amenable to potentially curative treatment with radiation therapy or surgery. 4. Patients with a history of psychiatric disorders that would interfere with consent or follow-up. 5. Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy. 6. Patients with a history of prior malignancy (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer) or other cancer for which the patient has been disease-free for at least five years. 7. Pregnant or lactating women. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. 8. Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible. 9. Patients with any other severe concurrent disease which would make the patient inappropriate for entry into this study, including significant hepatic, renal, or gastrointestinal diseases. 10. Patients with deep venous or arterial thrombosis (including pulmonary embolism) within 6 weeks of study entry. 11. Patients with \>/= grade 2 hypercholesterolemia or hypertriglyceridaemia (fasting state), despite lipid lowering therapy should be excluded from entering the study. 12. Patients currently taking any of the medications listed in Appendix A (Patients will be given a listing of these medications at the time of the informed consent). 13. Known hypersensitivity to everolimus, sirolimus or excipients including hydroxytoluene, magnesium stearate, hydroxypropylmethyl-cellulose, crospovidone and lactulose.