Bevacizumab and Temsirolimus in Treating Patients With Recurrent or Persistent Endometrial Cancer

Inclusion Criteria

• Histologically confirmed endometrial carcinoma (from primary tumor) including any of the following cell types:
• Endometrioid adenocarcinoma
• Serous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial carcinoma
• Adenocarcinoma not otherwise specified
• Mucinous adenocarcinoma
• Squamous cell carcinoma
• Transitional cell carcinoma
• Mesonephric carcinoma
• Recurrent or persistent disease that is refractory to curative therapy or established treatments
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Must have ≥ 1 target lesion to assess response as defined by RECIST
• Tumors within a previously irradiated field are designated as "non-target" lesions in the absence of documented disease progression or a biopsy to confirm persistence for ≥ 90 days after completion of radiotherapy
• Must have received 1 prior chemotherapeutic regimen for management of endometrial carcinoma
• May have received 1 additional cytotoxic regimen for management of this disease
• Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, including any active GOG Phase III protocol for patients with endometrial carcinoma
• No history or evidence of CNS disease, including primary brain tumor or any brain metastases upon physical examination
• GOG performance status (PS) 0-2 (for patients who have received 1 prior regimen) OR PS 0-1 (for patients who have received 2 prior regimens)
• ANC ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Urine protein: creatinine ratio 150 mm Hg or diastolic BP > 90 mm Hg
• Myocardial infarction or unstable angina within the past 6 months
• New York Heart Association class II-IV congestive heart failure
• Serious cardiac arrhythmia requiring medication
• Peripheral vascular disease ≥ grade 2
• No cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
• No uncontrolled diabetes
• Hemoglobin A1C 3 years prior to study and remain disease-free)
• No significant traumatic injury within the past 28 days
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
• Concurrent prophylactic or therapeutic anticoagulation* (e.g., warfarin) allowed
• Recovered from recent surgery, radiotherapy, or chemotherapy
• No prior bevacizumab or other VEGF pathway-targeted therapy
• No prior temsirolimus, everolimus, deforolimus, sirolimus, or any other mTor/PI3K pathway-targeted therapy
• No prior non-cytotoxic chemotherapy for management of this disease, except hormonal therapy
• At least 1 week since prior hormonal therapy directed at the malignant tumor
• No prior therapy that contraindicates this protocol therapy
• No prior radiotherapy to any portion of the abdominal cavity or pelvis within the past 5 years, except treatment of endometrial cancer
• Prior radiotherapy for localized cancer of the breast, head and neck, or skin is allowed, provided it was completed > 3 years prior to study entry and patient remains free of recurrent or metastatic disease
• No prior chemotherapy for any abdominal or pelvic tumor within the past 5 years, except treatment of endometrial cancer
• Prior adjuvant chemotherapy for localized breast cancer allowed, provided it was completed > 3 years prior to study entry and the patient remains free of recurrent or metastatic disease
• Prior treatment with an anthracycline (i.e., doxorubicin and/or liposomal doxorubicin) allowed provided ejection fraction < 50%
• More than 28 days since prior major surgery or open biopsy
• More than 7 days since minor surgical procedures, fine needle aspirates, or core biopsies
• At least 3 weeks since prior therapy directed at the malignant tumor, including immunologi